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Investigation of Dental Plaque and Gingival Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00759031
First received: September 23, 2008
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.


Condition Intervention Phase
Dental Plaque
 Drug: Sodium Monofluorophosphate
Drug: Triclosan/Fluoride/Copolymer
 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: Investigation of Dental Plaque and Gingival Index

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Gingival Margin Plaque Index [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.


Enrollment: 19
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A - Marketed fluoride toothpaste Drug: Sodium Monofluorophosphate
Brush teeth and evaluate plaque score after one use of the study toothpaste
Other Name: Colgate Great Regular Flavor toothpaste
Active Comparator: B -Triclosan/NaF/CoPolymer toothpaste Drug: Triclosan/Fluoride/Copolymer
Brush teeth and evaluate plaque score after one use of the study toothpaste
Other Name: Colgate Total toothpaste

  Eligibility

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

Inclusion Criteria:

  • Be aged 18 to 65 years inclusive
  • Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
  • Give written informed consent
  • Be in good general health
  • Must discontinue oral hygiene for 24-hrs.after initial appointment.
  • No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Advanced periodontal disease
  • 5 or more decayed, untreated dental sites
  • Diseases of the soft or hard oral tissues
  • Orthodontic appliances
  • Abnormal salivary function
  • Use of drugs that can currently affect salivary flow
  • Use of antibiotics one (1) month prior to or during this study
  • Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn)
  • Pregnant or breastfeeding.
  • Participation in another clinical study in the month preceding this study
  • Allergic to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759031

Locations
United States, New York
Boston University School of Dental Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Patricia Corby, DDS
  More Information

No publications provided

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00759031     History of Changes
Other Study ID Numbers: CRO-2007-PLA-23-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013