Phase 3
N=103
Compare the Clinical Efficacy of Prototype Toothpastes.
Gingival Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00761930 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Dental Plaque — 2.273; 1.806; 2.041 Units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluoride (Drug); Triclosan and fluoride (Drug); Herbal Ingredient and fluoride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dental Plaque |
2.273; 1.806; 2.041 | <0.05 sig |
| PRIMARY Gingivitis Score |
0.942; 0.722; 0.705 | <0.05 sig |
| PRIMARY Bleeding Index (EIBI) |
0.325; 0.164; 0.141 | <0.05 sig |
Summary
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque 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 16 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.
- Dental Selection Criteria: Average full mouth GI score should be in the range of
- - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
- (Quigley-Hein) to be in the range of 1.5-3.0
- If of child bearing potential and on birth control (diaphragm, birth control pills,
- Birth control implants, IUD (Intrauterine device), condoms)
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
- 2 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 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.
- History of allergy to common dentifrice ingredients
- Presence of an orthodontic appliance which interferes with plaque scoring.
- History of allergy to natural remedies, such as herbal ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Smoker
Data sourced from ClinicalTrials.gov (NCT00761930). 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.