Clinical trial NCT04123665: A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: Oral Health
Antiplaque
Gingivitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

  1. Currently taking antibiotics or requiring antibiotic use prior to dental prophylaxis or other dental procedures.
  2. Currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
  3. Currently taking a systemic medication which, in the opinion of the Investigator, could affect gingival condition (e.g. calcium channel blockers, or aspirin therapy).
  4. Current use of a chlorhexidine mouthwash. Baseline (Visit 2)
  5. Currently taking antibiotics or taken antibiotics in the previous 14 days or requiring antibiotic use prior to dental prophylaxis or other dental procedures.
  6. Has taken an anti-inflammatory medication which, in the opinion of the investigator, could affect gingival condition in the previous 14 days.
  7. 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

  1. 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.
  2. Restorations in a poor state of repair.
  3. Partial dentures or orthodontic appliances.
  4. Teeth bleaching within 12 weeks of screening.
* Clinical Study/Experimental Medication

  1. Participation in another clinical study or receipt of an investigational drug or investigational oral care product within 30 days of the Baseline Visit.
  2. Previous participation in this study.
* Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
* Personnel:

  1. Employed by the sponsor or the study site or members of their immediate family.
  2. 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.

Primary outcomes:
measure: Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks
timeFrame: At Week 24
Secondary outcomes:
measure: Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks
timeFrame: At Week 12
measure: Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
measure: Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
measure: Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
measure: Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
measure: Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
measure: Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
Other outcomes:
measure: Number of Bleeding Sites After 12 and 24 Weeks
timeFrame: At Week 12 and Week 24
Locations:
city: Fort Wayne
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.