Compare the Clinical Efficacy of Prototype Toothpastes.

NCT00761930 | Completed Phase 3 Results

• 1 other identifier: CRO-2007-GIN-04-RR
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

A

PLACEBO COMPARATOR

commercially available Fluoride toothpaste

Drug: Fluoride

B

ACTIVE COMPARATOR

fluoride/triclosan/copolymer toothpaste

Drug: Triclosan and fluoride

C

EXPERIMENTAL

fluoride/herbal toothpaste

Drug: Herbal Ingredient and fluoride

Interventions

Fluoride DRUG

Brush twice daily

Also known as: Colgate Great Regular Flavor toothpaste

A

Triclosan and fluoride DRUG

Brush twice daily

Also known as: Colgate Total toothpaste

B

Herbal Ingredient and fluoride DRUG

Brush twice daily

C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Eastman Dental Center - University of Rochester

Rochester, New York, 14642-8315, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Interventions

Fluorides; Triclosan; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William Devizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Yanfang Ren, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 15, 2013
• Results First Posted: October 20, 2010

Record last verified: 2013-08

Locations

US (1)