Training and Calibration of Dental Examiners

Phase 3

Completed

• Conditions: Dental Plaque
• Interventions: Drug: Triclosan; Drug: Chlorhexidine gluconate; Drug: Fluoride

• Registration Number: NCT00765167
• Lead Sponsor: Colgate Palmolive

Brief Summary

Training and calibration of dental examiners

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-30
• Status Verified: 2008-10
• Study First Posted: 2008-10-02
• Last Update Submitted: 2008-10-02
• Last Update Posted: 2008-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Male or female volunteers 18-65 years of age
• Good general health
• Must sign informed consent form
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
• 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

1. Subjects unable or unwilling to sign the informed consent form.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease or heavy dental tartar (calculus).
4. 2 or more decayed untreated dental sites at screening.
5. Other disease of the hard or soft oral tissues.
6. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
7. Use of medications that can affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
8. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
9. Pregnant or nursing women.
10. Participation in any other clinical study within 1 week prior to enrollment into this study.
11. Allergy to chlorhexidine
12. Use of tobacco products
13. Subjects who must receive dental treatment during the study dates.
14. Current use of Antibiotics for any purpose.
15. Presence of an orthodontic appliance.
16. History of allergy to common dentifrice ingredients.
17. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Triclosan	-
B	Fluoride	-
C	Chlorhexidine gluconate	-
A	Fluoride	-

Primary Outcome Measures

Name	Time	Method
Dental plaque	6 weeks

Trial Locations

Locations (1)

UMDNJ Dental School; 🇺🇸 Newark, New Jersey, United States