Compare the Clinical Efficacy of Prototype Toothpastes.
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00761930
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
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Purpose
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation
| Condition | Intervention | Phase |
|---|---|---|
|
Gingival Diseases |
Drug: Fluoride Drug: Triclosan and fluoride Drug: Herbal Ingredient and fluoride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Compare the Clinical Efficacy of Prototype Toothpastes. |
Resource links provided by NLM:
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- Dental Plaque [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
- Gingivitis Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
- Bleeding Index (EIBI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
| Enrollment: | 103 |
| Study Start Date: | March 2008 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
commercially available Fluoride toothpaste
|
Drug: Fluoride
Brush twice daily
Other Name: Colgate Great Regular Flavor toothpaste
|
|
Active Comparator: B
fluoride/triclosan/copolymer toothpaste
|
Drug: Triclosan and fluoride
Brush twice daily
Other Name: Colgate Total toothpaste
|
|
Experimental: C
fluoride/herbal toothpaste
|
Drug: Herbal Ingredient and fluoride
Brush twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761930
Locations
| United States, New York | |
| Eastman Dental Center - University of Rochester | |
| Rochester, New York, United States, 14642-8315 | |
Sponsors and Collaborators
Colgate Palmolive
Investigators
| Principal Investigator: | Yanfang Ren, DDS |
More Information
No publications provided
| Responsible Party: | William DeVizio/VP - Clinical Research, Colgate Palmolive |
| ClinicalTrials.gov Identifier: | NCT00761930 History of Changes |
| Other Study ID Numbers: | CRO-2007-GIN-04-RR |
| Study First Received: | September 26, 2008 |
| Results First Received: | August 19, 2010 |
| Last Updated: | June 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Gingival Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases Fluorides Triclosan Hexachlorophene Cariostatic Agents Protective Agents Physiological Effects of Drugs |
Pharmacologic Actions Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013