COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024738
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : December 3, 2009
Last Update Posted : December 3, 2009
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Fluoride Drug: Triclosan, fluoride Drug: Chlorhexidine Gluconate Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Study Start Date : March 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Plaque Index [ Time Frame: 4 Days ]
    Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01024738

Layout table for location information
United States, New Jersey
TKL Research, Inc.
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Colgate Palmolive
Layout table for investigator information
Principal Investigator: Mark LeFelt, DDS
Layout table for additonal information
Responsible Party: William DeVizio/VP, Colgate Palmolive Identifier: NCT01024738    
Other Study ID Numbers: CRO-2008-PLA-05-RR
First Posted: December 3, 2009    Key Record Dates
Results First Posted: December 3, 2009
Last Update Posted: December 3, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
Layout table for 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