The Clinical Investigation of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in Thailand
Overview
- Phase
- Phase 2
- Intervention
- Meridol
- Conditions
- Gingivitis
- Sponsor
- Colgate Palmolive
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Plaque Assessment
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group 1
Toothpaste
Intervention: Meridol
Group II
Toothpaste
Intervention: Colgate Cavity Protection
Outcomes
Primary Outcomes
Plaque Assessment
Time Frame: 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
Gingivitis Assessment
Time Frame: 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.