Clinical trial NCT02750943: Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease
Official title: A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 253
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* 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.

ii. Currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.

iii. 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.

iii. 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.

Primary outcomes:
measure: Number of Bleeding Sites at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Bleeding Sites at Week 4
timeFrame: Week 4
measure: Bleeding Index (BI) at Week 4 and Week 12
timeFrame: Week 4, Week 12
measure: Modified Gingival Index (MGI) at Week 4 and Week 12
timeFrame: Week 4, Week 12
measure: Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
timeFrame: Week 4, Week 12
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: