Compare the Clinical Efficacy of Prototype Toothpastes.

• ClinicalTrials.gov Identifier: NCT00761930
• Recruitment Status: Completed
• First Posted: September 30, 2008
• Results First Posted: October 20, 2010
• Last Update Posted: August 15, 2013
• Sponsor: Colgate Palmolive
• Information provided by: Colgate Palmolive

Study Description

Brief Summary:

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Condition or disease	Intervention/treatment	Phase
Gingival Diseases	Drug: Fluoride; Drug: Triclosan and fluoride; Drug: Herbal Ingredient and fluoride	Phase 3

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• 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
• Results First Posted: October 20, 2010
• Last Update Posted: August 15, 2013
• Last Verified: August 2013

Additional relevant MeSH terms:

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