Gingivitis
Conditions
Brief summary
Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.
Detailed description
A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.
Interventions
0.454% stannous fluoride toothpaste
DRUGColgate fluoride toothpaste
0.76 % Sodium MonoFluorophosphate (MFP)
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female volunteers aged 18-70 years 2. In good general health, ASA I 3. No clinical signs of gingival inflammation at \>90% sites observed 4. Probing Depth (PD) \< 3.0 mm 5. Attachment Loss (AL) = 0 mm 6. No periodontal disease history 7. Non-smokers 8. Fluent in English
Exclusion criteria
1. Presence of orthodontic bands. 2. Presence of partial removal dentures. 3. Tumour(s) of the soft or the hard tissues of the oral cavity. 4. Cavitated carious lesions requiring immediate restorative treatment. 5. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study. 6. Participation in any other clinical study or test panel with a one month period prior to entering the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Index (BOP) and Oral Inflammatory Load | during patient visit over the 9 weeks | BOP is a bleeding index standard in field, oral inflammatory load as measured by neutrophil levels in oral rinses |
Countries
Canada
Outcome results
None listed