Phase 3
N=102
Compare the Clinical Efficacy of Prototype Toothpastes
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT00926029 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Plaque Index — 0.91; 0.84; 1.77 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluoride (Drug); Triclosan, fluoride (Drug); Metal salt (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Index |
0.91; 0.84; 1.77 | 0.05 |
| PRIMARY Gingivitis Index |
0.63; 0.51; 0.98 | 0.05 |
Summary
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers 18-65 years of age.
- Good general health.
- Must sign informed consent form.
- Minimum of 20 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
- Subject 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.
- 5 or more decayed untreated dental sites at screening.
- 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 currently affect salivary flow.
- 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.
- History of allergy to common dentifrice ingredients.
- History of allergy to zinc.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Data sourced from ClinicalTrials.gov (NCT00926029). 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.