Training and Calibration of Dental Examiners

NCT ID: NCT00765167

Last Updated: 2008-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2007-12-31

Brief Summary

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Training and calibration of dental examiners

Detailed Description

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Conditions

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush half mouth twice daily for four days

B

Group Type ACTIVE_COMPARATOR

Triclosan

Intervention Type DRUG

Brush half mouth daily for four days

Fluoride

Intervention Type DRUG

Brush half mouth daily for four days

C

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate

Intervention Type DRUG

Mouth rinsing with 15 ml for 30 seconds twice a day for four days

Interventions

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Fluoride

Brush half mouth twice daily for four days

Intervention Type DRUG

Triclosan

Brush half mouth daily for four days

Intervention Type DRUG

Chlorhexidine gluconate

Mouth rinsing with 15 ml for 30 seconds twice a day for four days

Intervention Type DRUG

Fluoride

Brush half mouth daily for four days

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Colgate Palmolive

Principal Investigators

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Michael Deasy, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

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UMDNJ Dental School

Newark, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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ATO-2007-PLA-01-RR

Identifier Type: -

Identifier Source: org_study_id