Phase 2
N=28
Evaluating Commercial Anti-Plaque Products and Oral Rinse
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT01014143 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Plaque Index — 2.63; 2.65; 1.23 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoride (Drug); Chlorhexidine digluconate (Drug); Fluoride, triclosan (Drug)
- Age
- Adult, Older Adult · 23+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Index |
2.63; 2.65; 1.23 | 0.05 |
Summary
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers at least 18 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
- 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).
- Two 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 are currently affect salivary function.
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
- Allergy to chlorhexidine.
- 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 pre-medication for dental treatment or for any other purpose.
- Presence of an orthodontic appliance that interferes with plaque scoring.
- History of allergy to common dentifrice ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Data sourced from ClinicalTrials.gov (NCT01014143). 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.