Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gingivitis
- Sponsor
- Colgate Palmolive
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- change in mean dental plaque
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.
Detailed Description
A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects had to be between the ages of 18 and 70 (inclusive),
- •Subjects needed to be available for the duration (6 weeks) of the study,
- •Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
- •Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,
- •Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,
- •Subjects had to sign an Informed Consent form,
- •Subjects had to be in general good health and
- •Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.
- •Medical condition which require pre-medication prior to dental visits/procedures,
- •The presence of partial removable dentures,
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
change in mean dental plaque
Time Frame: 3 and 6 weeks of product use
Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject.
change in mean gingivitis
Time Frame: 3 and 6 weeks of product use
gingivitis measurement is served as secondary efficacy variable