Overview
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Status:
Completed
Completed
Trial end date:
2007-12-01
2007-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Colgate PalmoliveTreatments:
Fluorides
Triclosan
Criteria
Inclusion Criteria:- Availability for the six-month duration of the 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.
- Use of antibiotics any time during the one month 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.
- Pregnant women or women who are breast feeding.
- Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
- History of allergic to personal care/consumer products or their ingredients.
- Taking any prescription medicines. That might interfere with the study outcome.
- Individuals with an existing medical condition which prohibits them from not eating or
drinking for periods up to 4 hours.