Status:

COMPLETED

Evaluate Clinical Research From Commerical Oral Care Products

Lead Sponsor:

Colgate Palmolive

Conditions:

Gingival Diseases

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

Detailed Description

The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Eligibility Criteria

Inclusion

  • 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

  • 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) requiring more than one visit of cleaning sessions
  • 2 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 can 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.
  • Allergy to chlorhexidine
  • 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.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00759187

Start Date

January 1 2008

End Date

April 1 2008

Last Update

March 4 2010

Active Locations (1)

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1

Boston University School of Dental Medicine

Boston, Massachusetts, United States, 02118