Train New Examiners Via Modified Gingival Margin Plaque

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758563
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008
  Purpose

The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.


Condition Intervention Phase
Dental Plaque
Drug: Fluoride
Drug: Triclosan/Fluoride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Train New Examiners Via Modified Gingival Margin Plaque

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Mean Gingival Plaque Units [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Fluoride
Brush twice daily
Active Comparator: B Drug: Triclosan/Fluoride
Brush twice daily

  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
  • Must discontinue oral hygiene for 24-hrs.after initial appointment.
  • 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
  • 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.
  • 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
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: NCT00758563

Locations
United States, Pennsylvania
Northampton Community College
Bethlehem, Pennsylvania, United States, 18020
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Terry Sigal-Greene
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00758563     History of Changes
Other Study ID Numbers: CRO-0907-PLA-18-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: November 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Stomatognathic Diseases
Tooth Diseases
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 20, 2014