Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

NCT00966953 | Completed Phase 3 Results

• 1 other identifier: ERO-0907-PLA-16-RR
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (1)

• Plaque Index

  Plaque score scale: 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)

  8 weeks

Study Arms (4)

Fluoride Toothpaste

PLACEBO COMPARATOR

fluoride control

Drug: Fluoride

Total/Whitening

ACTIVE COMPARATOR

positive control

Drug: Triclosan/Fluoride toothpaste

antibacterial plant extract 1

EXPERIMENTAL

Honokiol

Drug: Fluoride

antibacterial plant extract 2

EXPERIMENTAL

magnolol

Drug: Fluoride; Other: antibacterial plant extract

Interventions

Fluoride DRUG

Brush twice daily

Fluoride Toothpaste

Triclosan/Fluoride toothpaste DRUG

Brush twice daily

Total/Whitening

antibacterial plant extract OTHER

Brush twice daily

Also known as: Honokiol

antibacterial plant extract 2

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.
• Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
• 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.

You may not qualify if:

• Medical condition which requires pre-medication prior to dental procedures/visits.
• Medical condition which precludes eating/drinking for 12 hrs.
• History of allergy to common dentifrice ingredients.
• Subjects unable or unwilling to sign the informed consent form.
• Moderate or advanced periodontal disease.
• Two 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 can currently affect salivary flow.
• Current use of antibiotics.
• 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 30 days prior to enrollment into this study.
• Use of tobacco products.
• Subjects who must receive dental treatment during the study dates.

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; honokiol

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 - DMD
• Organization: Colgate Palmolive

william_devizio@colpal.com

732-878-7901

Study Officials

• Yanfang Ren, DDS

  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: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: August 27, 2009
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 22, 2009
• Results First Posted: August 27, 2009

Record last verified: 2009-09

Locations

US (1)