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Training and Calibration of Dental Examiners

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ClinicalTrials.gov Identifier: NCT00765167
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : October 3, 2008
Information provided by:
Colgate Palmolive

Brief Summary:
Training and calibration of dental examiners

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Triclosan Drug: Chlorhexidine gluconate Phase 3

Study Type : Interventional  (Clinical Trial)
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 : November 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

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

Primary Outcome Measures :
  1. Dental plaque [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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:

  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765167

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

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
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: October 3, 2008
Last Verified: October 2008

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