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

Gingival Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966953
• Other study ID #: ERO-0907-PLA-16-RR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: September 14, 2009
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: September 2009
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Current use of Antibiotics for any purpose.

• Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Drug:
• Fluoride
Brush twice daily
• Triclosan/Fluoride toothpaste
Brush twice daily
• Fluoride
Brush twice daily
• Fluoride
Brush twice daily

Other:
• antibacterial plant extract
Brush twice daily

Locations

Country	Name	City	State
United States	Eastman Dental Center - University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index		8 weeks	No