A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride

Completed · Phase 3

Conditions studied: Gingivitis

In brief

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.

Key facts

Study ID

NCT04123665

Run by

GlaxoSmithKline

People needed

98

Starts

2013-05-28

Expected to finish

2013-12-11

Last updated by the study team

2020-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• GSK Investigational Site — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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