Compare the Clinical Efficacy of Prototype Toothpastes.

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

Study Overview

• Status: Completed
• Conditions: Gingival Diseases
• Intervention / Treatment: Drug: Fluoride; Drug: Triclosan and fluoride; Drug: Herbal Ingredient and fluoride

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642-8315
      • Eastman Dental Center - University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B; fluoride/triclosan/copolymer toothpaste	Drug: Triclosan and fluoride; Brush twice daily; Other Names: Colgate Total toothpaste
Placebo Comparator: A; commercially available Fluoride toothpaste	Drug: Fluoride; Brush twice daily; Other Names: Colgate Great Regular Flavor toothpaste
Experimental: C; fluoride/herbal toothpaste	Drug: Herbal Ingredient and fluoride; Brush twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Plaque	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.	6 weeks
Gingivitis Score	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.	6 weeks
Bleeding Index (EIBI)	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.	6 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Yanfang Ren, DDS

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 15, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Protective Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cariostatic Agents; Fatty Acid Synthesis Inhibitors; Listerine; Fluorides; Sodium Fluoride; Triclosan
• Other Study ID Numbers: CRO-2007-GIN-04-RR