Gingivitis, Plaque, Dental
Conditions
Brief summary
Triple Blinded Randomized Clinical trial study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of established dental plaque and gingivitis.
Interventions
DRUGColgate SNaP Total 10/10, 1.5 Taurate
0.454% SnF 1100 ppm F , 1.5 Taurate
0.76% Na MFP, (1000 ppm F)
OTHERFlat Trimmed Extra Clean TB
manual toothbrush
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the twenty four-week(6 month) duration of the clinical research study. * Good general health based on the opinion of the study investigator * Minimum of 20 permanent natural teeth (excluding third molars). * Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification)
Exclusion criteria
* Presence of orthodontic appliances. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study. * Five or more carious lesions requiring immediate restorative treatment. * Antibiotic use any time during the one-month period prior to entry into the study. * Participation in any other clinical study or test panel within the one month prior to entry into the study. * Dental prophylaxis during the past two weeks prior to baseline examinations. * History of allergies to oral care/personal care consumer products or their ingredients. * On any prescription medicines that might interfere with the study outcome. * An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours. * History of alcohol and/or drug abuse. * Self-reported pregnancy and/or lactating subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loe-Silness Gingival Index | baseline, 12 weeks, 24 weeks | score from 0 to 3 will be assigned by the examining dentist Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesiolingual; 5) mid-lingual; and 6) disto-lingual |
| Quigley-Hein Plaque Index | baseline, 12 weeks, 24 weeks | score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth. Each tooth is scored for supragingival plaque on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual |
Countries
United States
Outcome results
None listed