Extrinsic Dental StainNCT03160703
Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
A study testing Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica, Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%) and Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80 in people with Extrinsic Dental Stain and Oral Hygiene, run by GlaxoSmithKline at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Extrinsic Dental Stain, Oral Hygiene
- What is being tested?
- Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica, Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%) and Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jul 2017to 25 Aug 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral examination which could impact study outcomes, Absence of any condition that would impact on subject safety or wellbeing, or affect the subject's ability to understand and follow study procedures and requirements.
- In the opinion of the investigator or medically qualified designee, At screening: Good oral health, at least 16 natural teeth including the 12 anterior teeth, the facial surfaces, and mandibular lingual surfaces, of at least 11 of the 12 anterior teeth, gradable for the MLSI, presence of extrinsic dental stain (judged to be formed due to dietary factors, or use of tobacco products) on the facial surfaces of the anterior teeth, as determined from a visual stain assessment. At baseline: A sufficient level of extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the scorable anterior (maxillary and mandibular) teeth.
Who cannot join
- Women who are known to be pregnant, or who are intending to become pregnant over the duration of the study. Since this study is not being conducted under an IND this information will be self-reported, and not diagnosed through the conduct of urinary pregnancy testing.
- Women who are breast-feeding.
- Recent history (within the last year) of alcohol or other substance abuse.
- Concurrent Medication: Current regular use of mouthwashes containing ingredients that are known to impart staining. For example, chlorhexidine or cetylpyridinium chloride (CPC), Use of minocycline, tetracycline or doxycycline within 30 days prior to screening, Use of minocycline, tetracycline or doxycycline between the screening and baseline visit, Daily doses of a medication and/or traditional/herbal ingredients which, in the opinion of the investigator, may affect study outcomes. For example, drugs or supplements containing metal ions known to impart staining to the enamel.
- Disease: Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes, Any condition which, in the opinion of the investigator, causes xerostomia.
- Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Show all 11Show fewer
- Clinical study/Experimental Product:Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit, Previous participation in this study.
- General dentition exclusions: Dental prophylaxis within 8 weeks of screening, Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening, Use of any professionally dispensed or over the counter bleaching/ whitening products (excluding daily use whitening dentifrices) within the past 3 months.
- Specific Dentition Exclusions for Test Teeth: Any tooth which, in the opinion of the investigator, appears to be non-vital based on changes in the intrinsic colour, tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening, tooth with exposed dentine which, in the opinion of the investigator, could impact grading of extrinsic dental stain; tooth with deep, defective or facial restorations; tooth used as an abutment for fixed or removable partial dentures; tooth with full crown or veneer, orthodontic bands or cracked enamel, tooth with surface irregularities, discoloration due to trauma, tetracycline stain, restorations, or hypo or hyperplasic areas which, in the opinion of the investigator, would prevent consistent grading of extrinsic dental stain.
- Personnel: An employee of the sponsor or the study site or members of their immediate family.
- Other: Any subject who, in the judgment of the investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Principal Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice.
Read the detailed description
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be used to evaluate and compare the stain buildup of two 0.454% SnF2/ 5% STP dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice. Stain will be assessed following a full professional dental prophylaxis, at intervals over a 4 week treatment period, using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Participants will be stratified by pre-prophylaxis MLSI score (total MLSI Area x Intensity (A×I) for the facial surfaces of the 12 anterior teeth) and smoking status. The study will be conducted in healthy participants with a propensity for extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the anterior teeth.
- Conditions
- Extrinsic Dental Stain, Oral Hygiene
- Being tested
- Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica, Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%), Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80, Stannous fluoride (SnF2, 0.454%), RDA~120
- Keywords
- Dental stain, stannous fluoride, dentifrice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silicaOther
Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica (RDA~58) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%)Other
Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica (RDA~77) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80Other
Participants will apply a full brush head of their dentifrice containing 1000 ppm fluoride as SMFP with moderate abrasivity (RDA~80) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
Stannous fluoride (SnF2, 0.454%), RDA~120Other
Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 with higher abrasivity (RDA~120) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
| Study group | Role | What they receive |
|---|---|---|
| Test dentifrice 1 (RDA~58) | Experimental | Participants will apply experimental dentifrice containing 0.454% SnF2 / 5% STP. Receives: Other: Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica |
| Test dentifrice 2 (RDA~77) | Experimental | Participants will apply experimental dentifrice containing 0.454% SnF2 / 5% STP. Receives: Other: Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%) |
| Reference dentifrice 1 (RDA~80) | Other | Participants will apply dentifrice containing 1000 parts per million (ppm) fluoride as Sodium Monofluorophosphate (SMFP). Receives: Other: Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80 |
| Reference dentifrice 2 (RDA~120) | Active comparator | Participants will apply dentifrice containing 0.454% SnF2. Receives: Other: Stannous fluoride (SnF2, 0.454%), RDA~120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start10 Jul 2017
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extrinsic Dental StainStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, randomised, examiner blind, parallel design study to evaluate the buildup of extrinsic dental stain over a 4 week treatment period
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160703
- Sponsor's protocol ID
- 207872
- Status last verified
- May 2019
- First submitted
- 18 May 2017
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mason S, Young S, Qaqish J, Frappin G, Goyal C. Stain control with two modified stannous fluoride/sodium tripolyphosphate toothpastes: A randomised controlled proof of concept study. J Dent. 2019;91S:100009. doi: 10.1016/j.jjodo.2019.100009. Epub 2019 Oct 7.
PubMed 34059275
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Principal Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
- ClinicalTrials.gov ID
- NCT03160703
- Acronym / sponsor ID
- 207872
- Conditions
- Extrinsic Dental Stain, Oral Hygiene
- Keywords
- Dental stain, stannous fluoride, dentifrice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 17 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice.
Detailed description
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be used to evaluate and compare the stain buildup of two 0.454% SnF2/ 5% STP dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice. Stain will be assessed following a full professional dental prophylaxis, at intervals over a 4 week treatment period, using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Participants will be stratified by pre-prophylaxis MLSI score (total MLSI Area x Intensity (A×I) for the facial surfaces of the 12 anterior teeth) and smoking status. The study will be conducted in healthy participants with a propensity for extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the anterior teeth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Single centre, randomised, examiner blind, parallel design study to evaluate the buildup of extrinsic dental stain over a 4 week treatment period
| Arm | Type | Receives |
|---|---|---|
| Test dentifrice 1 (RDA~58) | Experimental | Other: Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silicaParticipants will apply experimental dentifrice containing 0.454% SnF2 / 5% STP. |
| Test dentifrice 2 (RDA~77) | Experimental | Other: Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%)Participants will apply experimental dentifrice containing 0.454% SnF2 / 5% STP. |
| Reference dentifrice 1 (RDA~80) | Other | Other: Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80Participants will apply dentifrice containing 1000 parts per million (ppm) fluoride as Sodium Monofluorophosphate (SMFP). |
| Reference dentifrice 2 (RDA~120) | Active comparator | Other: Stannous fluoride (SnF2, 0.454%), RDA~120Participants will apply dentifrice containing 0.454% SnF2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral examination which could impact study outcomes, Absence of any condition that would impact on subject safety or wellbeing, or affect the subject's ability to understand and follow study procedures and requirements.
- In the opinion of the investigator or medically qualified designee, At screening: Good oral health, at least 16 natural teeth including the 12 anterior teeth, the facial surfaces, and mandibular lingual surfaces, of at least 11 of the 12 anterior teeth, gradable for the MLSI, presence of extrinsic dental stain (judged to be formed due to dietary factors, or use of tobacco products) on the facial surfaces of the anterior teeth, as determined from a visual stain assessment. At baseline: A sufficient level of extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the scorable anterior (maxillary and mandibular) teeth.
Key exclusion criteria (11 listed)
- Women who are known to be pregnant, or who are intending to become pregnant over the duration of the study. Since this study is not being conducted under an IND this information will be self-reported, and not diagnosed through the conduct of urinary pregnancy testing.
- Women who are breast-feeding.
- Recent history (within the last year) of alcohol or other substance abuse.
- Concurrent Medication: Current regular use of mouthwashes containing ingredients that are known to impart staining. For example, chlorhexidine or cetylpyridinium chloride (CPC), Use of minocycline, tetracycline or doxycycline within 30 days prior to screening, Use of minocycline, tetracycline or doxycycline between the screening and baseline visit, Daily doses of a medication and/or traditional/herbal ingredients which, in the opinion of the investigator, may affect study outcomes. For example, drugs or supplements containing metal ions known to impart staining to the enamel.
- Disease: Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes, Any condition which, in the opinion of the investigator, causes xerostomia.
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 |
|---|---|---|
| Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silicaParticipants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica (RDA~58) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Test dentifrice 1 (RDA~58) |
| Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%)Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica (RDA~77) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Test dentifrice 2 (RDA~77) |
| Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80Participants will apply a full brush head of their dentifrice containing 1000 ppm fluoride as SMFP with moderate abrasivity (RDA~80) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Reference dentifrice 1 (RDA~80) |
| Stannous fluoride (SnF2, 0.454%), RDA~120Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 with higher abrasivity (RDA~120) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate. | Other | Reference dentifrice 2 (RDA~120) |
Primary outcome
Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
Time frame: Baseline and Week 4
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34059275Mason S, Young S, Qaqish J, Frappin G, Goyal C. Stain control with two modified stannous fluoride/sodium tripolyphosphate toothpastes: A randomised controlled proof of concept study. J Dent. 2019;91S:100009. doi: 10.1016/j.jjodo.2019.100009. Epub 2019 Oct 7.
- Individual participant dataSharing planned: No
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica, Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%) and Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80 in people with Extrinsic Dental Stain and Oral Hygiene, run by GlaxoSmithKline at 1 site in Canada.
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 4 inclusion and 11 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 Jun 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 Canada. 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 17 Jan 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?
Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160703, which also lists 1 linked publication.
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 Jun 2019.