Training and Calibration of Dental Examiners

Sponsor

Colgate Palmolive (Industry)

Overall Status

Completed

CT.gov ID

NCT00765167

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Training and calibration of dental examiners

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Drug: Fluoride Drug: Triclosan Drug: Chlorhexidine gluconate Drug: Fluoride	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Training and Calibration of Dental Examiners

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A	Drug: Fluoride Brush half mouth twice daily for four days
Active Comparator: B	Drug: Triclosan Brush half mouth daily for four days Drug: Fluoride Brush half mouth daily for four days
Active Comparator: C	Drug: Chlorhexidine gluconate Mouth rinsing with 15 ml for 30 seconds twice a day for four days

Arm

Intervention/Treatment

Placebo Comparator: A

Drug: Fluoride

Brush half mouth twice daily for four days

Active Comparator: B

Drug: Triclosan

Brush half mouth daily for four days

Drug: Fluoride

Brush half mouth daily for four days

Active Comparator: C

Drug: Chlorhexidine gluconate

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

Outcome Measures

Primary Outcome Measures

Dental plaque [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Subjects unable or unwilling to sign the informed consent form.
Medical condition which requires pre-medication prior to dental visits/procedures
Moderate or advanced periodontal disease or heavy dental tartar (calculus).
2 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 affect salivary flow (e.g. anticholinergics, adrenergics, antihistamines, vasoconstrictors or decongestants).
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 1 week prior to enrollment into this study.
Allergy to chlorhexidine
Use of tobacco products
Subjects who must receive dental treatment during the study dates.
Current use of Antibiotics for any purpose.
Presence of an orthodontic appliance.
History of allergy to common dentifrice ingredients.
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMDNJ Dental School	Newark	New Jersey	United States	07101

Sponsors and Collaborators

Colgate Palmolive

Investigators

Principal Investigator: Michael Deasy, DDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00765167

Other Study ID Numbers:

ATO-2007-PLA-01-RR

First Posted:

Oct 2, 2008

Last Update Posted:

Oct 3, 2008

Last Verified:

Oct 1, 2008

Additional relevant MeSH terms:

Dental Plaque

Chlorhexidine

Chlorhexidine gluconate

Triclosan

Fluorides

Study Results

No Results Posted as of Oct 3, 2008