GingivitisPhase 3NCT04123665
A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride
A Phase 3 study testing Stannous fluoride and Sodium monofluorophosphate in people with Gingivitis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight [w/w] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Stannous fluoride and Sodium monofluorophosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2013to 11 Dec 2013
- Phase
- Phase 3
- 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
- Consent :Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health: Good general and mental health with, in the opinion of the investigator, no clinically significant and relevant abnormalities of medical history or oral examination.
- Dental Health: A minimum of 20 natural teeth and a minimum of 40 gradable surfaces for: a) MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth count; b) Moderate gingivitis present at the screening visit in the opinion of the investigator; c) Mean whole mouth MGI between 1.75 and 2.30 and mean whole mouth supra-gingival PI score 1.5 at Baseline Visit.
Who cannot join
- Pregnancy and breast-feeding: Women who are known to be pregnant or who are intending to become pregnant or women who are breast-feeding over the duration of the study.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Tobacco Use: Current smokers or smokers who have quit within the past six months, prior to screening, or participants currently using smokeless forms of tobacco - e.g. chewing tobacco.
- Concomitant Medications - Treatments Screening (Visit 1)
- Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures.
- Currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
Show all 24Show fewer
- Currently taking a systemic medication which, in the opinion of the Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
- Current use of a chlorhexidine mouthwash. Baseline (Visit 2)
- Currently taking antibiotics or taken antibiotics in the previous 14 days or requiring antibiotic use prior to dental prophylaxis or other dental procedures.
- Has taken an anti-inflammatory medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days.
- Has taken a systemic medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).
- General Dentition Exclusions
- Current active caries or periodontitis that may, in the opinion of the investigator, compromise the study outcomes or oral health of the participants if they participate in the study.
- Restorations in a poor state of repair.
- Partial dentures or orthodontic appliances.
- Teeth bleaching within 12 weeks of screening.
- Clinical Study/Experimental Medication
- Participation in another clinical study or receipt of an investigational drug or investigational oral care product within 30 days of the Baseline Visit.
- Previous participation in this study.
- Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
- Personnel:
- Employed by the sponsor or the study site or members of their immediate family.
- Employed by any dentifrice manufacturer or their immediate family.
- Other Conditions: Any condition that would impact on the safety of the participant or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice
The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight [w/w] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.
Read the detailed description
This will be a single-center, examiner-blinded, randomized, stratified, two-treatment parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. Eligible participants will be stratified based on gender and baseline mean whole mouth modified gingival index (MGI) score (Low: less than or equal to [<=] 2.00/High greater than [>]2.00) to ensure a balance in gingivitis across both treatment groups, and then randomized into one of two treatment groups. Treatment effect will be evaluated by comparing MGI , bleeding index and plaque index scores after 12 and 24 weeks use of a dentifrice containing 0.454% w/w stannous fluoride to a negative control dentifrice. During the 24 week treatment period, participants will apply a full ribbon of dentifrice to the head of a study toothbrush and brush their teeth in their usual manner at home for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
- Conditions
- Gingivitis
- Being tested
- Stannous fluoride, Sodium monofluorophosphate
- Keywords
- Oral Health, Antiplaque, Gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous fluorideDrug
In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
Sodium monofluorophosphateDrug
Also called Colgate Cavity Protection®, USA marketed dentifrice
In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as SMFP to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Test Dentifrice | Experimental | In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. Receives: Drug: Stannous fluoride |
| Control Dentifrice | Placebo comparator | In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as sodium monofluorophosphate [SMFP] to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. Receives: Drug: Sodium monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60[degrees(deg)] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds[sec])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results.
Measured: At Week 24
Secondary outcomes (7)
Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth (7in each arch). 3 scores were recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant were probed first (app 30 sec) before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding observed. Lower scores indicate better results.
Measured: At Week 12
Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks
BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High: >2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results.
Measured: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High: >2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results.
Measured: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks
MGI- to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (7 in each arch). 2scores recorded buccally/labially, 2scores lingually/palatally. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-4). Scoring was performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results.
Measured: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks
MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High:>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results.
Measured: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High:>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results.
Measured: At Week 12 and Week 24
Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
Turesky Modification of Quigley Hein Plaque Index-to assess plaque on all gradable teeth. Participants rinsed the plaque in dye solution of 5milliliters(mL)of solution for 10 sec, then expectorated and rinsed with 10 mL of water for 10 sec and then expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-5). Disclosed plaque scored as:0=no plaque, 1=slight flecks of plaque at the cervical margin of the tooth,2=a thin continuous band of plaque (1mm or smaller) at the cervical margin of the tooth, 3=a band of plaque wider than 1mm but covering less than 1/3 of the area, 4=plaque covering at least 1/3 but less than 2/3 of the area,5=plaque covering 2/3 or more of the crown of the tooth. Lower scores indicate better results.
Measured: At Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start28 May 2013
- Primary completion11 Dec 2013
- Study completion11 Dec 2013
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 GingivitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 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
- NCT04123665
- Sponsor's protocol ID
- 202687
- Status last verified
- Jan 2020
- First submitted
- 10 Oct 2019
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Parkinson CR, Milleman KR, Milleman JL. Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial. BMC Oral Health. 2020 Mar 26;20(1):89. doi: 10.1186/s12903-020-01079-6.
PubMed 32216778
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice
- ClinicalTrials.gov ID
- NCT04123665
- Acronym / sponsor ID
- 202687
- Conditions
- Gingivitis
- Keywords
- Oral Health, Antiplaque, Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 May 2013 (actual)
- Primary completion
- 11 Dec 2013 (actual)
- Study completion
- 11 Dec 2013 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 31 Jan 2020
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 gingival health of a test dentifrice (0.454% weight by weight [w/w] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.
Detailed description
This will be a single-center, examiner-blinded, randomized, stratified, two-treatment parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. Eligible participants will be stratified based on gender and baseline mean whole mouth modified gingival index (MGI) score (Low: less than or equal to [<=] 2.00/High greater than [>]2.00) to ensure a balance in gingivitis across both treatment groups, and then randomized into one of two treatment groups. Treatment effect will be evaluated by comparing MGI , bleeding index and plaque index scores after 12 and 24 weeks use of a dentifrice containing 0.454% w/w stannous fluoride to a negative control dentifrice. During the 24 week treatment period, participants will apply a full ribbon of dentifrice to the head of a study toothbrush and brush their teeth in their usual manner at home for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Test Dentifrice | Experimental | Drug: Stannous fluorideIn this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. |
| Control Dentifrice | Placebo comparator | Drug: Sodium monofluorophosphateIn this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as sodium monofluorophosphate [SMFP] to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consent :Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health: Good general and mental health with, in the opinion of the investigator, no clinically significant and relevant abnormalities of medical history or oral examination.
- Dental Health: A minimum of 20 natural teeth and a minimum of 40 gradable surfaces for: a) MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or extensively restored or grossly carious teeth are not included in the tooth count; b) Moderate gingivitis present at the screening visit in the opinion of the investigator; c) Mean whole mouth MGI between 1.75 and 2.30 and mean whole mouth supra-gingival PI score 1.5 at Baseline Visit.
Key exclusion criteria (24 listed)
- Pregnancy and breast-feeding: Women who are known to be pregnant or who are intending to become pregnant or women who are breast-feeding over the duration of the study.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Tobacco Use: Current smokers or smokers who have quit within the past six months, prior to screening, or participants currently using smokeless forms of tobacco - e.g. chewing tobacco.
- Concomitant Medications - Treatments Screening (Visit 1)
- General Dentition Exclusions
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 fluorideIn this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. | Drug | Experimental Test Dentifrice |
| Sodium monofluorophosphateAlso: Colgate Cavity Protection®, USA marketed dentifriceIn this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as SMFP to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. | Drug | Control Dentifrice |
Primary outcome
Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks
Time frame: At Week 24
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60[degrees(deg)] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds[sec])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results.
7 secondary outcomes
Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks
Time frame: At Week 12
Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks
Time frame: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
Time frame: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks
Time frame: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks
Time frame: At Week 12 and Week 24
Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
Time frame: At Week 12 and Week 24
Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
Time frame: At Week 12 and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32216778Parkinson CR, Milleman KR, Milleman JL. Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial. BMC Oral Health. 2020 Mar 26;20(1):89. doi: 10.1186/s12903-020-01079-6.
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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 Phase 3 study testing Stannous fluoride and Sodium monofluorophosphate in people with Gingivitis, run by GlaxoSmithKline 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 4 inclusion and 24 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 31 Jan 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). 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?
Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks (time frame: At Week 24). 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 NCT04123665, 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 31 Jan 2020.