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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Gingival Diseases

Treatments: Drug: Fluoride; Other: antibacterial plant extract; Drug: Triclosan/Fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT00966953

ERO-0907-PLA-16-RR

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

25 participants in 4 patient groups, including a placebo group

Fluoride Toothpaste

Placebo Comparator group

Description:

fluoride control

Treatment:

Drug: Fluoride

Drug: Fluoride

Drug: Fluoride

Total/Whitening

Active Comparator group

Description:

positive control

Treatment:

Drug: Triclosan/Fluoride toothpaste

antibacterial plant extract 1

Experimental group

Description:

Honokiol

Treatment:

Drug: Fluoride

Drug: Fluoride

Drug: Fluoride

antibacterial plant extract 2

Experimental group

Description:

magnolol

Treatment:

Drug: Fluoride

Drug: Fluoride

Drug: Fluoride

Other: antibacterial plant extract