Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

NCT00926328 | Completed Phase 3 Results

• 1 other identifier: CRO-0507-PL-SP-CT-BS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.

Conditions

Gingivitis

Keywords

Gingivitis and Plaque

Outcome Measures

Primary Outcomes (2)

• Gingivitis Index

  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)

  6 months

• Plaque Index

  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)

  6 Months

Study Arms (2)

A -Experimental toothpaste

ACTIVE COMPARATOR

triclosan/copolymer/fluoride toothpaste

Drug: Triclosan, fluoride

B - control toothpaste

PLACEBO COMPARATOR

sodium fluoride only toothpaste (placebo)

Drug: Fluoride

Interventions

Triclosan, fluoride DRUG

Six Month study, brush twice daily

Also known as: Colgate Total Advanced Freshening toothpaste

A -Experimental toothpaste

Fluoride DRUG

twice daily usage

Also known as: Crest Cavity Protection toothpaste

B - control toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability for the six-month duration of the study.
• Good general health.
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
• Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
• Signed Informed Consent Form.

You may not qualify if:

• Presence of orthodontic bands.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
• periodontal attachment or alveolar bone).
• Five or more carious lesions requiring immediate restorative treatment.
• Use of antibiotics any time during the one month prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry
• into the study.
• Pregnant women or women who are breast feeding.
• Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
• History of allergic to personal care/consumer products or their ingredients.
• Taking any prescription medicines. That might interfere with the study outcome.
• Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Dr. Fernando Autran

Barcelona, Spain

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Interventions

Triclosan; Fluorides; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: William De Vizio, DMD
• Organization: Colgate Palmolive

William_Devizio@colpal.com

732-878-7901

Study Officials

• Augusto E Boneta, DDS

  Dental Research Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: June 23, 2009
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 15, 2013
• Results First Posted: June 23, 2009

Record last verified: 2013-08

Locations

ES (1)