Dental HealthNCT01009554
Oral Tissue Tolerance of a Mouthrinse
A study testing Potassium Oxylate Mouthwash and Sodium Fluoride Dentifrice in people with Dental Health, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Health
- What is being tested?
- Potassium Oxylate Mouthwash and Sodium Fluoride Dentifrice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females at least 18 years of age and in good general and oral health.
- Volunteers must read, sign, and receive a signed copy of the Informed Consent Form after the nature of the study has been fully explained.
- Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the study.
- Willingness to refrain from using any breath freshener products or unassigned oral care products (i.e., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops, mouthwashes or teeth whitening products) throughout the duration of the study.
- Willingness to refrain from using any whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation.
- A minimum of 16 natural teeth, including at least 10 of the 12 anterior teeth (#6-11, #22-27, however, #7-10 must be present), with scorable facial and lingual surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
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- Classic Vita® Shade minimum value of A2 or darker on at least 2 of the 4 maxillary anterior teeth (#7-10).
- Absence of abnormal or severely fissured tongue, geographic tongue, tongue piercing or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- Absence of neglected dental health (i.e. gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systemically-related gingival enlargement, tissue damage due to ill-fitting appliances or restoration, or extreme crowding or overlapping of teeth
Who cannot join
- Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
- Prior participation in any oral hygiene or product clinical study within the previous 30 days.
- Therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tooth color or stain formation (i.e., certain antimicrobial mouthrinses and antibiotics, such as chlorhexidine).
- Restorations on 10% or more of the facial surfaces of the maxillary anterior incisor teeth.
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- Dental fluorosis, hypoplasia, restorations, tetracycline stains, or other enamel surface irregularities that may interfere with evaluation of the selected teeth.
- Visual evidence of Moderate/advanced periodontitis (ADA Type III, IV). Orthodontic bands, appliances, bridges, numerous crowns, removable orthodontic appliances or partial dentures.
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Regular use of whitening products within 1 week prior to Screening/Baseline. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for the entry into this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.
Read the detailed description
This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4). Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste. Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.
- Conditions
- Dental Health
- Being tested
- Potassium Oxylate Mouthwash, Sodium Fluoride Dentifrice
- Keywords
- Mouthwashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Oxylate MouthwashDevice
Also called Formula 11794-050
Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice
Sodium Fluoride DentifriceDrug
Also called Regular Cavity Protection toothpaste
Brush in usual manner, twice daily, with a sodium fluoride dentifrice
| Study group | Role | What they receive |
|---|---|---|
| Potassium Oxylate | Experimental | 1.5% potassium oxalate sensitive mouthwash Receives: Device: Potassium Oxylate Mouthwash |
| Sodium Fluoride | Active comparator | Sodium Fluoride Dentifrice Receives: Drug: Sodium Fluoride Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Measured: 8 weeks
Oral Tissue Tolerance
Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.
Measured: through 8 weeks
Secondary outcomes (62)
Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Measured: 4 weeks
Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Measured: 6 weeks
Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Measured: 4 weeks
Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Measured: 6 weeks
Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.
Measured: 8 weeks
Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Measured: 4 weeks
Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Measured: 6 weeks
Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.
Measured: 8 weeks
Mean Stain Score Over All Tooth Sites at 4 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 4 weeks
Mean Stain Score Over All Tooth Sites at 6 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 6 weeks
Mean Stain Score Over All Tooth Sites at 8 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 8 weeks
Mean Stain Intensity Over All Tooth Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 4 weeks
Mean Stain Intensity Over All Tooth Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 6 weeks
Mean Stain Intensity Over All Tooth Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 8 weeks
Mean Stain Area Over All Tooth Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 4 weeks
Mean Stain Area Over All Tooth Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 6 weeks
Mean Stain Area Over All Tooth Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 8 weeks
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 4 weeks
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 6 weeks
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 8 weeks
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 4 weeks
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 6 weeks
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 8 weeks
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Measured: 4 weeks
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Measured: 6 weeks
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Measured: 8 weeks
Mean Stain Score for Gingival Sites at 4 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 4 weeks
Mean Stain Score for Gingival Sites at 6 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 6 weeks
Mean Stain Score for Gingival Sites at 8 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 8 weeks
Mean Stain Intensity for Gingival Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 4 weeks
Mean Stain Intensity for Gingival Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 6 weeks
Mean Stain Intensity for Gingival Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 8 weeks
Mean Stain Area for Gingival Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Measured: 4 weeks
Mean Stain Area for Gingival Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Measured: 6 weeks
Mean Stain Area for Gingival Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
Measured: 8 weeks
Mean Stain Score for Body Sites at 4 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 4 weeks
Mean Stain Score for Body Sites at 6 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 6 weeks
Mean Stain Score for Body Sites at 8 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 8 weeks
Mean Stain Intensity for Body Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 4 weeks
Mean Stain Intensity for Body Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 6 weeks
Mean Stain Intensity for Body Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 8 weeks
Mean Stain Area for Body Sites at 4 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 4 weeks
Mean Stain Area for Body Sites at 6 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 6 weeks
Mean Stain Area for Body Sites at 8 Weeks
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 8 weeks
Mean Stain Score for Facial Sites at 4 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 4 weeks
Mean Stain Score for Facial Sites at 6 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 6 weeks
Mean Stain Score for Facial Sites at 8 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 8 weeks
Mean Stain Intensity for Facial Sites at 4 Weeks
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 4 weeks
Mean Stain Intensity for Facial Sites at 6 Weeks
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 6 weeks
Mean Stain Intensity for Facial Sites at 8 Weeks
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 8 weeks
Mean Stain Area for Facial Sites at 4 Weeks
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 4 weeks
Mean Stain Area for Facial Sites at 6 Weeks
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 6 weeks
Mean Stain Area for Facial Sites at 8 Weeks
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 8 weeks
Mean Stain Score for Lingual Sites at 4 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 4 weeks
Mean Stain Score for Lingual Sites at 6 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 6 weeks
Mean Stain Score for Lingual Sites at 8 Weeks
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
Measured: 8 weeks
Mean Stain Intensity for Lingual Sites at 4 Weeks
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 4 weeks
Mean Stain Intensity for Lingual Sites at 6 Weeks
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 6 weeks
Mean Stain Intensity for Lingual Sites at 8 Weeks
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
Measured: 8 weeks
Mean Stain Area for Lingual Sites at 4 Weeks
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 4 weeks
Mean Stain Area for Lingual Sites at 6 Weeks
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 6 weeks
Mean Stain Area for Lingual Sites at 8 Weeks
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lynch, DMD, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009554
- Sponsor's protocol ID
- UNKPLT0002
- Status last verified
- Jun 2015
- First submitted
- 5 Nov 2009
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse
- ClinicalTrials.gov ID
- NCT01009554
- Acronym / sponsor ID
- UNKPLT0002
- Conditions
- Dental Health
- Keywords
- Mouthwashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Posted 3 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.
Detailed description
This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4). Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste. Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Oxylate | Experimental | Device: Potassium Oxylate Mouthwash1.5% potassium oxalate sensitive mouthwash |
| Sodium Fluoride | Active comparator | Drug: Sodium Fluoride DentifriceSodium Fluoride Dentifrice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females at least 18 years of age and in good general and oral health.
- Volunteers must read, sign, and receive a signed copy of the Informed Consent Form after the nature of the study has been fully explained.
- Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the study.
- Willingness to refrain from using any breath freshener products or unassigned oral care products (i.e., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops, mouthwashes or teeth whitening products) throughout the duration of the study.
- Willingness to refrain from using any whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation.
Key exclusion criteria (10 listed)
- Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
- Prior participation in any oral hygiene or product clinical study within the previous 30 days.
- Therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tooth color or stain formation (i.e., certain antimicrobial mouthrinses and antibiotics, such as chlorhexidine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium Oxylate MouthwashAlso: Formula 11794-050Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice | Device | Potassium Oxylate |
| Sodium Fluoride DentifriceAlso: Regular Cavity Protection toothpasteBrush in usual manner, twice daily, with a sodium fluoride dentifrice | Drug | Sodium Fluoride |
Primary outcome
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
Time frame: 8 weeks
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.
Oral Tissue Tolerance
Time frame: through 8 weeks
Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.
62 secondary outcomes
Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
Time frame: 4 weeks
Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
Time frame: 6 weeks
Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
Time frame: 4 weeks
Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
Time frame: 6 weeks
Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
Time frame: 8 weeks
Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment
Time frame: 4 weeks
Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment
Time frame: 6 weeks
Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment
Time frame: 8 weeks
Mean Stain Score Over All Tooth Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Score Over All Tooth Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Score Over All Tooth Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Intensity Over All Tooth Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Intensity Over All Tooth Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Intensity Over All Tooth Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Area Over All Tooth Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Area Over All Tooth Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Area Over All Tooth Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Score for Gingival Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Score for Gingival Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Score for Gingival Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Intensity for Gingival Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Intensity for Gingival Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Intensity for Gingival Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Area for Gingival Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Area for Gingival Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Area for Gingival Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Score for Body Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Score for Body Sites at 6 Weeks
Time frame: 6 weeks
Mean Stain Score for Body Sites at 8 Weeks
Time frame: 8 weeks
Mean Stain Intensity for Body Sites at 4 Weeks
Time frame: 4 weeks
Mean Stain Intensity for Body Sites at 6 Weeks
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lynch, DMD, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium Oxylate Mouthwash and Sodium Fluoride Dentifrice in people with Dental Health, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.