Phase 3
N=22
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT01024738 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Plaque Index — 3.31; 3.31; 2.91 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluoride (Drug); Triclosan, fluoride (Drug); Chlorhexidine Gluconate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Index |
3.31; 3.31; 2.91 | 0.05 |
Summary
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Eligibility Criteria
Inclusion Criteria
- Be aged 18 to 65 years inclusive
- Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
- If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
Exclusion Criteria
- Medical condition which requires pre-medication (antibiotics) prior to dental
- Visits/procedures
- Allergy to chlorhexidine
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
- Diseases of the soft or hard oral tissues (gums or palate)
- Orthodontic appliances that interfere with plaque rating
- Abnormal salivary function
- Use of drugs that can affect currently salivary flow or production
- Use of antibiotics one (1) month prior to or during this study
- Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
- Pregnant or breastfeeding.
- Participation in another research study in the month preceding this study
- Allergic to common toothpaste or mouth rinse ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Data sourced from ClinicalTrials.gov (NCT01024738). 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.