Compare the Clinical Efficacy of Prototype Toothpastes.
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ClinicalTrials.gov Identifier: NCT00761930 |
Recruitment Status :
Completed
First Posted : September 30, 2008
Results First Posted : October 20, 2010
Last Update Posted : August 15, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gingival Diseases | Drug: Fluoride Drug: Triclosan and fluoride Drug: Herbal Ingredient and fluoride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Compare the Clinical Efficacy of Prototype Toothpastes. |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- Dental Plaque [ Time Frame: 6 weeks ]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 ]
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 ]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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761930
United States, New York | |
Eastman Dental Center - University of Rochester | |
Rochester, New York, United States, 14642-8315 |
Principal Investigator: | Yanfang Ren, DDS |
Responsible Party: | William DeVizio/VP - Clinical Research, Colgate Palmolive |
ClinicalTrials.gov Identifier: | NCT00761930 |
Other Study ID Numbers: |
CRO-2007-GIN-04-RR |
First Posted: | September 30, 2008 Key Record Dates |
Results First Posted: | October 20, 2010 |
Last Update Posted: | August 15, 2013 |
Last Verified: | August 2013 |
Gingival Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases Listerine Triclosan Fluorides Sodium Fluoride Cariostatic Agents |
Protective Agents Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |