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Effect on Bacterial Glycolytic Acid Formation on Plaque
This study has been completed.
Sponsored by: Colgate Palmolive
Information provided by: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762450
  Purpose

To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.


Condition Intervention Phase
Dental Plaque
Drug: Triclosan
Drug: Herbal Ingredient
Drug: Fluoride
Phase III

Drug Information available for: Fluoride Triclosan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Official Title: Effect on Bacterial Glycolytic Acid Formation on Plaque

Further study details as provided by Colgate Palmolive:

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

Enrollment: 6
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: Triclosan
Rinse 3 times daily with assigned toothpaste slurry
Drug: Fluoride
Rinse 3 times daily with assigned toothpaste slurry
B: Placebo Comparator Drug: Herbal Ingredient
Rinse 3 times daily with assigned toothpaste slurry

  Eligibility

Ages Eligible for Study:   72 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Maxillary dentition is preferentially natural.
  • Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
  • Natural mandibular front teeth and first premolars (4-4) are retained.
  • Second mandibular molars are ideally present to serve as abutment teeth.
  • Mandibular restorations and/or reconstructions must be in clinically good condition.
  • Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
  • Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
  • Willingness to give their informed consent and comply with the protocol.
  • No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

  • Current participation in other dental clinical trials.
  • Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
  • Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
  • Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
  • Subjects taking drugs known to currently affect salivary flow.
  • Subjects with un-stimulated salivary flow <0.3 ml/min and/or stimulated flow <0.9 ml/min.
  • Women who are pregnant or breastfeeding
  • History of allergy to common dentifrice ingredients
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  • Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
  • Medical condition which requires premedication prior to dental procedures/visits
  • History of allergy to amino acids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762450

Locations
Switzerland
University of Zurich, Dental Institute Dept. of Preventive
Zurich, Switzerland
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Thomas Imfeld, MBA Unaffiliated
  More Information

No publications provided

Responsible Party: Colgate Palmolive ( William DeVizio/VP - Clinical Research )
Study ID Numbers: CRO-2008-PLA-01-AM
Study First Received: September 26, 2008
Last Updated: September 30, 2008
ClinicalTrials.gov Identifier: NCT00762450  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Tooth Diseases
Hexachlorophene
Stomatognathic Diseases
Fluorides
Triclosan
Dental Plaque

Additional relevant MeSH terms:
Dental Deposits

ClinicalTrials.gov processed this record on February 12, 2009