Evaluating Commercial Anti-Plaque Products and Oral Rinse

June 10, 2011 updated by: Colgate Palmolive
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

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
      • Northfield, New Jersey, United States, 08225
        • New Institutional Service Company

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

23 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female volunteers at least 18 years of age.
  • Good general health.
  • Must sign informed consent form.
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures.
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus).
  • Two or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that are currently affect salivary function.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Allergy to chlorhexidine.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this study.
  • Use of tobacco products.
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for pre-medication for dental treatment or for any other purpose.
  • Presence of an orthodontic appliance that interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

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
Drug: Fluoride
Half mouth toothbrushing twice a day for four days.
Other Names:
  • fluoride toothpaste
Active Comparator: Triclosan/Fluoride toothpaste
positive control toothpaste
Drug: Fluoride, triclosan
Half mouth Brushing twice daily
Other Names:
  • Total toothpaste
Active Comparator: Chlorhexidine Oral Rinse
Positive Control mouthrinse
Drug: Chlorhexidine digluconate
Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
Other Names:
  • Periogard oral rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: Four days
Plaque 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)
Four days

Collaborators and Investigators

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

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Matthew Cronin, 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

August 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Estimate)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 10, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2007-PLA-15-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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