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Training and Calibration of Dental Examiners

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan
Chlorhexidine gluconate
Fluoride
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • UMDNJ Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Dental plaque

Secondary Outcome Measures

Full Information

First Posted
September 23, 2008
Last Updated
October 2, 2008
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT00765167
Brief Title
Training and Calibration of Dental Examiners
Official Title
Training and Calibration of Dental Examiners
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Training and calibration of dental examiners

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush half mouth twice daily for four days
Intervention Type
Drug
Intervention Name(s)
Triclosan
Intervention Description
Brush half mouth daily for four days
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Intervention Description
Mouth rinsing with 15 ml for 30 seconds twice a day for four days
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush half mouth daily for four days
Primary Outcome Measure Information:
Title
Dental plaque
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Deasy, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ Dental School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States

12. IPD Sharing Statement

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Training and Calibration of Dental Examiners

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