Compare the Clinical Efficacy of Prototype Toothpastes

February 16, 2012 updated by: Colgate Palmolive
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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
      • Cedar Knolls, New Jersey, United States, 07927
        • Concordia Clinical Research

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female volunteers 18-65 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:

  • Subject 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.
  • 5 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 currently affect salivary flow.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • 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 any purpose.
  • Presence of an orthodontic appliance.
  • History of allergy to common dentifrice ingredients.
  • History of allergy to zinc.
  • 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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Fluoride control -A
Winterfresh Gel
Drug: Fluoride
Brush twice daily
Other Names:
  • Colgate Winterfresh Gel
ACTIVE_COMPARATOR: Triclosan/Fluoride - B
Positive control (Total toothpaste)
Drug: Triclosan, fluoride
Brush twice daily
Other Names:
  • Colgate Total toothpaste
EXPERIMENTAL: Triclosan/fluoride/metal salt- C
test toothpaste
Other: Metal salt
Brush twice daily
Other Names:
  • New toothpaste formula being evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: 6 weeks
Plaque Index score 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)
6 weeks
Gingivitis Index
Time Frame: 6 Weeks
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
6 Weeks

Collaborators and Investigators

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

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Salim A Nathoo, 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

January 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

May 5, 2009

First Posted (ESTIMATE)

June 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2007-GIN-06-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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