GingivitisNCT02750943
Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease
A study testing Stannous Fluoride and Sodium Monofluorophosphate in people with Gingivitis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in healthy adult volunteers with moderate gingivitis. 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?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 4 Mar 2016
- 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
- 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.
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- A minimum of 20 permanent gradable teeth. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
- Moderate gingivitis present at the screening visit in the opinion of the investigator from a gross visual gingival assessment.
- Visible blood in toothpaste expectorant at Screening and Baseline (Visit 2).
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
Show all 18Show fewer
- An employee of the sponsor or the study site or members of their immediate family.
- An employee of any toothpaste manufacturer or their immediate family.
- Medical History/Current Medication A. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity B.Screening i. 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.
- Currently taking a systemic medication which, in the opinion of the C. Baseline, Day 28 and Day 96 Assessment Visits i. Has taken antibiotics in the previous 14 days. ii. 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).could affect gingival condition in the previous 14 days (e.g. calcium channel blockers, or aspirin therapy).Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
- Have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the subjects 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.
- Use of a chlorhexidine mouthwash within 14 days of baseline.
- Current smokers or smokers who have quit within the past 6 months prior to screening or subjects currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala or nicotine based e-cigarettes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice
This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of a dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis and gingival bleeding following 12 weeks twice daily brushing, compared to a negative control dentifrice.
- Conditions
- Gingivitis
- Being tested
- Stannous Fluoride, Sodium Monofluorophosphate
- 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
Dentifrice containing 0.454% w/w stannous fluoride
Sodium MonofluorophosphateDrug
Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate
| Study group | Role | What they receive |
|---|---|---|
| Stannous Fluoride | Experimental | Participants will apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) Receives: Drug: Stannous Fluoride |
| Sodium Monofluorophosphate | Active comparator | Participants will apply a full ribbon of dentifrice containing Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) Receives: Drug: Sodium Monofluorophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bleeding Sites at Week 12
Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.
Measured: Week 12
Secondary outcomes (4)
Number of Bleeding Sites at Week 4
Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.
Measured: Week 4
Bleeding Index (BI) at Week 4 and Week 12
BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Measured: Week 4, Week 12
Modified Gingival Index (MGI) at Week 4 and Week 12
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 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 but involving the entire marginal or papillar gingival units; 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.
Measured: Week 4, Week 12
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood 'Present' (Trace or Substantial) or 'absent' in expectorate was analyzed.
Measured: Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start1 Nov 2015
- Primary completion1 Mar 2016
- Study completion4 Mar 2016
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 253 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
- NCT02750943
- Sponsor's protocol ID
- 205045
- Status last verified
- Sep 2016
- First submitted
- 2 Nov 2015
- Last updated
- 26 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice
- ClinicalTrials.gov ID
- NCT02750943
- Acronym / sponsor ID
- 205045
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2015
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 4 Mar 2016 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Posted 11 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center, 12 week, examiner-blind, randomized, stratified (gender and baseline mean whole mouth MGI score), two-treatment, parallel group, clinical study in healthy adult volunteers with moderate gingivitis. This study will evaluate the efficacy of a dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis and gingival bleeding following 12 weeks twice daily brushing, compared to a negative control dentifrice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stannous Fluoride | Experimental | Drug: Stannous FluorideParticipants will apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) |
| Sodium Monofluorophosphate | Active comparator | Drug: Sodium MonofluorophosphateParticipants will apply a full ribbon of dentifrice containing Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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.
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- A minimum of 20 permanent gradable teeth. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
- Moderate gingivitis present at the screening visit in the opinion of the investigator from a gross visual gingival assessment.
Key exclusion criteria (18 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
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 FluorideDentifrice containing 0.454% w/w stannous fluoride | Drug | Stannous Fluoride |
| Sodium MonofluorophosphateDentifrice containing 1000ppm fluoride as sodium monofluorophosphate | Drug | Sodium Monofluorophosphate |
Primary outcome
Number of Bleeding Sites at Week 12
Time frame: Week 12
Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.
4 secondary outcomes
Number of Bleeding Sites at Week 4
Time frame: Week 4
Bleeding Index (BI) at Week 4 and Week 12
Time frame: Week 4, Week 12
Modified Gingival Index (MGI) at Week 4 and Week 12
Time frame: Week 4, Week 12
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
Time frame: Week 4, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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 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 6 inclusion and 18 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 26 Oct 2017. 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 11 Nov 2016). 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?
Number of Bleeding Sites at Week 12 (time frame: Week 12). 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 26 Oct 2017.