Gingivitis, Plaque
Conditions
Brief summary
The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.
Interventions
DRUGMeridol
toothpaste
toothpaste
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
* Subjects, ages 18-70, inclusive. * Availability for the six-month duration of the clinical research study. * Good general health. * Minimum of 20 uncrowned 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). * Signed Informed Consent Form
Exclusion criteria
* Presence of orthodontic bands. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). * 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 or drinking for periods up to 4 hours. * History of alcohol or drug abuse. * Pregnant or lactating subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingivitis Assessment | baseline, 3 months and 6 months | 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. |
| Plaque Assessment | baseline, 3 months and 6 months | A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror |
Countries
Thailand
Outcome results
None listed