Dental Devices, Home CareNCT01224158
Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis
A study testing Experimental Power Toothbrush and Flat trimmed Manual Toothbrush in people with Dental Devices, Home Care, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Devices, Home Care
- What is being tested?
- Experimental Power Toothbrush and Flat trimmed Manual Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2010to 29 Oct 2010
- 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.
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
- Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial.
- Good general and oral health with manual dexterity.
- Willingness to refrain from all oral hygiene procedures within 18-24 hours prior to the study visit.
- A minimum of twenty scorable teeth with at least one scorable molar in each quadrant.
Show all 14Show fewer
- A whole-mouth mean plaque level greater than 0.60 at Day 0.
- Whole-mouth-mean gingivitis level greater than or equal to 1.75 at Day 0.
- Absence of orthodontic bands, appliances, bridges, numerous crowns, extensive large restorations, excessive caries, removable orthodontic appliances or partial dentures.
- Absence of significant oral soft tissue pathology, excluding gingivitis, based on the visual oral examination and at the discretion of the examiner.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- Absence of moderate/advanced periodontitis.
- Absence of extensive supragingival calculus.
- Absence of ulcerations on lips and oral mucosa.
Who cannot join
- Currently taking steroids, antibiotic medication or any other medication within the previous month that may interfere with the efficacy evaluations.
- Those requiring antibiotic premedication prior to dental treatment.
- Participation in a dental clinical trial involving oral care products currently or within the past 28 days.
- Dental prophylaxis within one week prior to enrollment into the study.
- 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 results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
- Self-reported pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Experimental Toothbrush on the Treatment and Prevention of Gingivitis
This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.
Read the detailed description
This is a 42-day, randomized, observer-blind, parallel group, single-center clinical trial. Generally healthy adults will be recruited from a database of known plaque formers. A sufficient number of subjects meeting the necessary inclusion/exclusion criteria will be enrolled into two groups, so that 140 subjects (70 per treatment group) would reasonably be expected to complete the study.
The study will have a pre-experimental phase, which will last 2 weeks followed by an experimental phase that is 4 weeks in duration. At the start of the pre-experimental phase (Day 0), subjects will undergo an initial oral exam, during which gingivitis and pre-brushing plaque evaluations will be performed. Supragingival plaque levels will be assessed on all scorable teeth according to the Rustogi Modified Navy Plaque Index (RMNPI) and gingivitis will be scored according to the Modified Gingival Index (MGI). Subjects with a whole mouth mean plaque level > 0.60 and a whole mouth mean MGI ≥ 1.75 will then brush their teeth with their assigned toothbrush using American Dental Association (ADA) Accepted fluoride toothpaste. They will be provided with written and verbal instructions to use their toothbrush twice a day, for the next 7 days (Normalization period), allowing the participants to get familiar with the assigned test product. During the second visit (Day 7), the subjects will return the products to the clinical site, and start the experimental gingivitis phase, during which they will only be allowed to use a placebo rinse (W002194-0221P) as means of oral hygiene. The objective of the experimental gingivitis phase is to standardize the levels of plaque and gingivitis in both groups.
At visit 3 (Day 14), subjects will undergo a second gingivitis and pre-brushing plaque evaluation and receive their assigned brush, instructions and diary. They will brush with their assigned toothbrush for two weeks (14 days), using an ADA accepted fluoride toothpaste. During the fourth visit (Day 28), the subjects will return to the site and undergo a third gingivitis and post-brushing plaque evaluation. At the last visit (Day 42), the study participants will undergo final gingivitis and post-brushing plaque evaluations and return all used products.
- Conditions
- Dental Devices, Home Care
- Being tested
- Experimental Power Toothbrush, Flat trimmed Manual Toothbrush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Power ToothbrushDevice
Also called Not yet marketed
Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day with the experimental toothbrush and toothpaste provided) moving to the next quadrant of the mouth at 30-second intervals.
Flat trimmed Manual ToothbrushDevice
Also called Reach®
Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day using the toothbrush and toothpaste provided) in their usual manner.
| Study group | Role | What they receive |
|---|---|---|
| PR-009577 Toothbrush | Experimental | Experimental Power Toothbrush Receives: Device: Experimental Power Toothbrush |
| PR-000172 Toothbrush | Active comparator | Flat trimmed Manual Toothbrush Receives: Device: Flat trimmed Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42
Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: Day 42
Secondary outcomes (5)
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28
Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale with score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: Day 28
Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the total score for all tooth sites assessed divided by the total number of tooth sites assessed.
Measured: Day 42
Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the total score for all tooth sites assessed divided by the total number of tooth sites assessed.
Measured: Day 28
Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42
Hard-to-reach mean score is defined as mean of scores over following areas combined; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across middle of tooth and I covers incisal area. Plaque was disclosed on a scale (0 indicates no dental plaque to 1 indicates dental plaque), Mean RPI overall was calculated for each participant as total score for all tooth sites assessed divided by total number of tooth sites assessed.
Measured: Day 28 and 42
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Hard-to-reach mean score is defined as mean of scores over following areas separately d; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across middle of tooth and I covers incisal area. Plaque on each area was assigned one of the following score: on a scale (0 indicates no dental plaque and 1 indicates plaque present in the measured segment of the tooth).
Measured: Day 28 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study start13 Sep 2010
- Primary completion29 Oct 2010
- Study completion29 Oct 2010
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 Devices, Home CareStudies 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo Araujo, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224158
- Sponsor's protocol ID
- TBRGBP0016
- Status last verified
- Nov 2019
- First submitted
- 15 Oct 2010
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Experimental Toothbrush on the Treatment and Prevention of Gingivitis
- ClinicalTrials.gov ID
- NCT01224158
- Acronym / sponsor ID
- TBRGBP0016
- Conditions
- Dental Devices, Home Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2010 (actual)
- Primary completion
- 29 Oct 2010 (actual)
- Study completion
- 29 Oct 2010 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Posted 4 Dec 2019
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 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.
Detailed description
This is a 42-day, randomized, observer-blind, parallel group, single-center clinical trial. Generally healthy adults will be recruited from a database of known plaque formers. A sufficient number of subjects meeting the necessary inclusion/exclusion criteria will be enrolled into two groups, so that 140 subjects (70 per treatment group) would reasonably be expected to complete the study.
The study will have a pre-experimental phase, which will last 2 weeks followed by an experimental phase that is 4 weeks in duration. At the start of the pre-experimental phase (Day 0), subjects will undergo an initial oral exam, during which gingivitis and pre-brushing plaque evaluations will be performed. Supragingival plaque levels will be assessed on all scorable teeth according to the Rustogi Modified Navy Plaque Index (RMNPI) and gingivitis will be scored according to the Modified Gingival Index (MGI). Subjects with a whole mouth mean plaque level > 0.60 and a whole mouth mean MGI ≥ 1.75 will then brush their teeth with their assigned toothbrush using American Dental Association (ADA) Accepted fluoride toothpaste. They will be provided with written and verbal instructions to use their toothbrush twice a day, for the next 7 days (Normalization period), allowing the participants to get familiar with the assigned test product. During the second visit (Day 7), the subjects will return the products to the clinical site, and start the experimental gingivitis phase, during which they will only be allowed to use a placebo rinse (W002194-0221P) as means of oral hygiene. The objective of the experimental gingivitis phase is to standardize the levels of plaque and gingivitis in both groups.
At visit 3 (Day 14), subjects will undergo a second gingivitis and pre-brushing plaque evaluation and receive their assigned brush, instructions and diary. They will brush with their assigned toothbrush for two weeks (14 days), using an ADA accepted fluoride toothpaste. During the fourth visit (Day 28), the subjects will return to the site and undergo a third gingivitis and post-brushing plaque evaluation. At the last visit (Day 42), the study participants will undergo final gingivitis and post-brushing plaque evaluations and return all used products.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PR-009577 Toothbrush | Experimental | Device: Experimental Power ToothbrushExperimental Power Toothbrush |
| PR-000172 Toothbrush | Active comparator | Device: Flat trimmed Manual ToothbrushFlat trimmed Manual Toothbrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females at least 18 years of age and in good general and oral health.
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
- Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial.
- Good general and oral health with manual dexterity.
- Willingness to refrain from all oral hygiene procedures within 18-24 hours prior to the study visit.
Key exclusion criteria (7 listed)
- Currently taking steroids, antibiotic medication or any other medication within the previous month that may interfere with the efficacy evaluations.
- Those requiring antibiotic premedication prior to dental treatment.
- Participation in a dental clinical trial involving oral care products currently or within the past 28 days.
- Dental prophylaxis within one week prior to enrollment into the study.
- 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 results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
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 |
|---|---|---|
| Experimental Power ToothbrushAlso: Not yet marketedFollowing a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day with the experimental toothbrush and toothpaste provided) moving to the next quadrant of the mouth at 30-second intervals. | Device | PR-009577 Toothbrush |
| Flat trimmed Manual ToothbrushAlso: Reach®Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day using the toothbrush and toothpaste provided) in their usual manner. | Device | PR-000172 Toothbrush |
Primary outcome
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42
Time frame: Day 42
Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
5 secondary outcomes
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28
Time frame: Day 28
Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42
Time frame: Day 42
Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28
Time frame: Day 28
Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42
Time frame: Day 28 and 42
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Time frame: Day 28 and 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Marcelo Araujo 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 Experimental Power Toothbrush and Flat trimmed Manual Toothbrush in people with Dental Devices, Home Care, 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 14 inclusion and 7 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 4 Dec 2019. 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 4 Dec 2019). 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?
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42 (time frame: Day 42). 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 4 Dec 2019.