Text Size

Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01024738
First received: September 26, 2008
Last updated: November 27, 2009
Last verified: October 2009
History of Changes
  Purpose

Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse


Condition Intervention Phase
Dental Plaque
 Drug: Fluoride
Drug: Triclosan, fluoride
Drug: Chlorhexidine Gluconate
 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: Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Plaque Index [ Time Frame: 4 Days ] [ Designated as safety issue: No ]

Enrollment: 22
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: Fluoride toothpaste
negative control toothpaste
 Drug: Fluoride
Brush half mouth twice daily for four days.
Active Comparator: Triclosan/Fluoride toothpaste
positive control toothpaste (Total toothpaste)
 Drug: Triclosan, fluoride
Brush twice daily
Other Name: Total toothpaste
Active Comparator: Chlorhexidine Oral Rinse
positive control oral rinse
 Drug: Chlorhexidine Gluconate
Rinse mouth twice a day

Detailed Description:

Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

  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 15 natural uncrowned teeth (excluding 3rd molars) present
  • Give written informed consent
  • Be in good general health
  • 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
  • If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

  • Medical condition which requires pre-medication (antibiotics) prior to dental
  • Visits/procedures
  • Allergy to chlorhexidine
  • Advanced periodontal disease (gum disease)
  • 5 or more decayed, untreated dental sites (cavities)
  • Diseases of the soft or hard oral tissues (gums or palate)
  • Orthodontic appliances that interfere with plaque rating
  • Abnormal salivary function
  • Use of drugs that can affect currently salivary flow or production
  • 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 research study in the month preceding this study
  • Allergic to common toothpaste or mouth rinse ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024738

Locations
United States, New Jersey
TKL Research, Inc.
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Mark LeFelt, DDS
  More Information

No publications provided

Responsible Party: William DeVizio/VP, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01024738     History of Changes
Other Study ID Numbers: CRO-2008-PLA-05-RR
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: November 27, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Triclosan
Hexachlorophene
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 May 19, 2013