Training and Calibration of Dental Examiners

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Dental Plaque

Treatments: Drug: Triclosan; Drug: Fluoride; Drug: Chlorhexidine gluconate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00765167

ATO-2007-PLA-01-RR

Details and patient eligibility

About

Training and calibration of dental examiners

Enrollment: 18 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
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Fluoride

Drug: Fluoride

B

Active Comparator group

Treatment:

Drug: Fluoride

Drug: Fluoride

Drug: Triclosan

C

Active Comparator group

Treatment:

Drug: Chlorhexidine gluconate