Training and Calibration of Dental Examiners

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00765167
First received: September 23, 2008
Last updated: October 2, 2008
Last verified: October 2008
  Purpose

Training and calibration of dental examiners


Condition Intervention Phase
Dental Plaque
Drug: Fluoride
Drug: Triclosan
Drug: Chlorhexidine gluconate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Training and Calibration of Dental Examiners

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Dental plaque [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765167

Locations
United States, New Jersey
UMDNJ Dental School
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Michael Deasy, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00765167     History of Changes
Other Study ID Numbers: ATO-2007-PLA-01-RR
Study First Received: September 23, 2008
Last Updated: October 2, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Triclosan
Fluorides
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 29, 2014