Phase 3
N=23
Clinical Study to Evaluate Dental Plaque
Gingival Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00758290 ↗Enrolled (actual)
23
Serious AEs
—
Results posted
Nov 2008
Primary outcome: Primary: Dental Plaque Index — 2.48; 2.42 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan/Fluoride (Drug); Fluoride/triclosan (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dental Plaque Index |
2.48; 2.42 | 0.05 |
Summary
Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers at least 20 - 51 years of age
- Good general health
- Must sign informed consent form
- Minimum of 15 natural uncrowned teeth (excluding third molars) must be present
- No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion Criteria
- Subjects unable or unwilling to sign the informed consent form
- Medical condition which requires pre-medication prior to dental visits/procedures
- Moderate or advanced periodontal disease or heavy dental tartar (calculus)
- 5 or more decayed untreated dental sites at screening (cavities)
- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- Use of medications that are currently affecting salivary function
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1
- Pregnant or nursing women
- Participation in any other clinical study within 1 week prior to enrollment into this study
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates
- Current use of Antibiotics for any purpose
- Presence of an orthodontic appliance which interferes with plaque scoring
- History of allergy to common toothpaste ingredients
- History of allergy to arginine (amino acid)
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Data sourced from ClinicalTrials.gov (NCT00758290). 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.