NCT03936569CompletedPhase 4
A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
Procter and Gamble1 site in 1 country90 target enrollmentStarted: October 29, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Löe-Silness Gingivitis Evaluation
Study Overview
Brief Summary
The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be at least 18 years of age;
- •Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
- •Have at least 16 gradable teeth;
- •Agree to return for scheduled visits and follow the study procedures;
- •Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
- •Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.
Exclusion Criteria
- •Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
- •Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
- •Removable oral appliances;
- •Fixed facial or lingual orthodontic appliances;
- •Self-reported pregnancy or lactation;
- •Any diseases or condition that might interfere with the safe participation in the study; and
- •Inability to undergo study procedures.
Arms & Interventions
Marketed Stannous Fluoride Toothpaste
Experimental
Brush twice daily
Intervention: Marketed Toothpaste (Drug)
Marketed Cavity Protection Toothpaste
Placebo Comparator
Brush twice daily
Intervention: Marketed Cavity Protection Toothpaste (Drug)
Outcomes
Primary Outcomes
Löe-Silness Gingivitis Evaluation
Time Frame: 3 Months
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Secondary Outcomes
- Turesky Modified Quigley-Hein Index(3 Months)
Investigators
Study Sites (1)
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