Phase 3
N=19
Investigation of Dental Plaque and Gingival Index
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT00759031 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2008
Primary outcome: Primary: Gingival Margin Plaque Index — 15.4; 12.81 Units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sodium Monofluorophosphate (Drug); Triclosan/Fluoride/Copolymer (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingival Margin Plaque Index |
15.4; 12.81 | 0.05 |
Summary
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
Eligibility Criteria
Inclusion Criteria
- Be aged 18 to 65 years inclusive
- Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
- 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
Exclusion Criteria
- Medical condition which requires pre-medication prior to dental visits/procedures
- Advanced periodontal disease
- 5 or more decayed, untreated dental sites
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
- Abnormal salivary function
- Use of drugs that can currently affect salivary flow
- 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 clinical study in the month preceding this study
- Allergic to common dentifrice ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Data sourced from ClinicalTrials.gov (NCT00759031). 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.