Gingivitis
Conditions
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.
Interventions
Marketed stannous fluoride (0.454%) toothpaste
Marketed sodium monofluorophosphate (0.76 %) toothpaste
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Turesky Modified Quigley-Hein Index | Baseline | The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth). |
Countries
United States
Outcome results
None listed