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

Completed · Phase 3

Conditions studied: Gingival Diseases

In brief

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

Key facts

Study ID

NCT00966953

Run by

Colgate Palmolive

People needed

25

Starts

2007-10-01

Expected to finish

2008-01-01

Last updated by the study team

2009-09-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• Current use of Antibiotics for any purpose.
• Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).

Where it is running

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

Full record on ClinicalTrials.gov

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