Phase 3
N=120
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT00926328 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Gingivitis Index — 1.00; 1.27 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan, fluoride (Drug); Fluoride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingivitis Index |
1.00; 1.27 | 0.05 |
| PRIMARY Plaque Index |
2.22; 2.88 | 0.05 |
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 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.
Data sourced from ClinicalTrials.gov (NCT00926328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.