Back to resultsEvaluating Commercial Anti-Plaque Products and Oral Rinse
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Chlorhexidine digluconate
Fluoride, triclosan
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
Eligibility Criteria
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).
Sites / Locations
- New Institutional Service Company
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Fluoride toothpaste
Triclosan/Fluoride toothpaste
Chlorhexidine Oral Rinse
Arm Description
Negative control
positive control toothpaste
Positive Control mouthrinse
Outcomes
Primary Outcome Measures
Plaque Index
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014143
Brief Title
Evaluating Commercial Anti-Plaque Products and Oral Rinse
Official Title
Evaluating Commercial Anti-Plaque Products and Oral Rinse
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.
Detailed Description
This clinical research study was to train new examiners for short term plaque clinical methodologies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride toothpaste
Arm Type
Placebo Comparator
Arm Description
Negative control
Arm Title
Triclosan/Fluoride toothpaste
Arm Type
Active Comparator
Arm Description
positive control toothpaste
Arm Title
Chlorhexidine Oral Rinse
Arm Type
Active Comparator
Arm Description
Positive Control mouthrinse
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
fluoride toothpaste
Intervention Description
Half mouth toothbrushing twice a day for four days.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine digluconate
Other Intervention Name(s)
Periogard oral rinse
Intervention Description
Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
Intervention Type
Drug
Intervention Name(s)
Fluoride, triclosan
Other Intervention Name(s)
Total toothpaste
Intervention Description
Half mouth Brushing twice daily
Primary Outcome Measure Information:
Title
Plaque Index
Description
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)
Time Frame
Four days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Cronin, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Institutional Service Company
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating Commercial Anti-Plaque Products and Oral Rinse
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