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

November 27, 2009 updated by: Colgate Palmolive
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • TKL Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Total toothpaste
Active Comparator: Chlorhexidine Oral Rinse
positive control oral rinse
Drug: Chlorhexidine Gluconate
Rinse mouth twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Mark LeFelt, DDS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

December 3, 2009

Last Update Submitted That Met QC Criteria

November 27, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2008-PLA-05-RR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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