Phase 3
N=73
Clinical Research Study Efficacy of a Prototype Oral Rinse
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT01021007 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Gingival Index — 1.90; 1.84 Units on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Iodine (Drug); water (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gingival Index |
1.90; 1.84 | 0.005 sig |
| PRIMARY EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale |
40.82; 34.91 | 0.05 |
| PRIMARY Plaque Index (Quigley-Hein Score) |
2.47; 2.11 | 0.05 |
Summary
Evaluate the efficacy of an oral rinse 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 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: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0
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
- History of allergy to iodine
- History of thyroid disease
- History of diabetes
- 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.
- Presence of an orthodontic appliance.
- History of allergy to common dentifrice ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
- Smoker
Data sourced from ClinicalTrials.gov (NCT01021007). 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.