Gingivitis, Plaque, Dental
Conditions
Brief summary
Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1, 3, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study
Interventions
DRUGTest regimen
toothpaste \& manual toothbrush
DRUGControl regimen
toothpaste \& 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 six-week 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 mean plaque index of at least 0.6 as determined by Navy Plaque index.
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 |
|---|---|---|
| Plaque assessment | Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks | The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas. |
| Gingivitis Assessment | Initial reading, 1-week, 3-weeks, and 6-weeks | A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Gallob, DMD
Consumer Research Consulting, LLC.
Outcome results
None listed