Status:
COMPLETED
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Lead Sponsor:
Colgate Palmolive
Conditions:
Gingivitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00926328
Start Date
June 1 2007
End Date
December 1 2007
Last Update
August 15 2013
Active Locations (1)
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1
Dr. Fernando Autran
Barcelona, Spain