Evaluating Commercial Anti-Plaque Products and Oral Rinse

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01014143
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011

September 26, 2008
June 10, 2011
August 2007
September 2007   (final data collection date for primary outcome measure)
Plaque Index [ Time Frame: Four days ] [ Designated as safety issue: No ]
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)
Plaque Index [ Time Frame: Four days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01014143 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Evaluating Commercial Anti-Plaque Products and Oral Rinse
Evaluating Commercial Anti-Plaque Products and Oral Rinse

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Plaque
  • Drug: Fluoride
    Half mouth toothbrushing twice a day for four days.
    Other Name: fluoride toothpaste
  • Drug: Chlorhexidine digluconate
    Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
    Other Name: Periogard oral rinse
  • Drug: Fluoride, triclosan
    Half mouth Brushing twice daily
    Other Name: Total toothpaste
  • Placebo Comparator: Fluoride toothpaste
    Negative control
    Intervention: Drug: Fluoride
  • Active Comparator: Triclosan/Fluoride toothpaste
    positive control toothpaste
    Intervention: Drug: Fluoride, triclosan
  • Active Comparator: Chlorhexidine Oral Rinse
    Positive Control mouthrinse
    Intervention: Drug: Chlorhexidine digluconate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2007
September 2007   (final data collection date for primary outcome measure)

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).
Both
23 Years to 81 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014143
CRO-2007-PLA-15-RR
No
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Matthew Cronin, DDS
Colgate Palmolive
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP