Effect on Bacterial Glycolytic Acid Formation on Plaque
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Triclosan, Fluoride
fluoride
Fluoride, triclosan, amino acid
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
Eligibility Criteria
Inclusion Criteria:
- Maxillary dentition is preferentially natural.
- Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
- Natural mandibular front teeth and first premolars (4-4) are retained.
- Second mandibular molars are ideally present to serve as abutment teeth.
- Mandibular restorations and/or reconstructions must be in clinically good condition.
- Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
- Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
- Willingness to give their informed consent and comply with the protocol.
- No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion Criteria:
- Current participation in other dental clinical trials.
- Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
- Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
- Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
- Subjects taking drugs known to currently affect salivary flow.
- Subjects with un-stimulated salivary flow <0.3 ml/min and/or stimulated flow <0.9 ml/min.
- Women who are pregnant or breastfeeding
- History of allergy to common dentifrice ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
- Medical condition which requires premedication prior to dental procedures/visits
- History of allergy to amino acids
Sites / Locations
- University of Zurich, Dental Institute Dept. of Preventive
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
A- Positive Control
B - Silica control
C- Experimental product
Arm Description
fluoride/triclosan/copolymer toothpaste
fluoride only toothpaste
fluoride/triclosan/amino acid toothpaste
Outcomes
Primary Outcome Measures
ph of Dental Plaque After Sucrose Challenge
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762450
Brief Title
Effect on Bacterial Glycolytic Acid Formation on Plaque
Official Title
Effect on Bacterial Glycolytic Acid Formation on Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
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 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A- Positive Control
Arm Type
Active Comparator
Arm Description
fluoride/triclosan/copolymer toothpaste
Arm Title
B - Silica control
Arm Type
Placebo Comparator
Arm Description
fluoride only toothpaste
Arm Title
C- Experimental product
Arm Type
Experimental
Arm Description
fluoride/triclosan/amino acid toothpaste
Intervention Type
Drug
Intervention Name(s)
Triclosan, Fluoride
Other Intervention Name(s)
Total+ Whitening toothpaste
Intervention Description
Rinse 3 times daily with assigned toothpaste slurry
Intervention Type
Drug
Intervention Name(s)
fluoride
Other Intervention Name(s)
placebo toothpaste (No triclosan, no amino acid)
Intervention Description
Rinse 3 times daily with assigned toothpaste slurry
Intervention Type
Drug
Intervention Name(s)
Fluoride, triclosan, amino acid
Intervention Description
Rinse 3 times daily with assigned toothpaste slurry
Primary Outcome Measure Information:
Title
ph of Dental Plaque After Sucrose Challenge
Description
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
72 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Maxillary dentition is preferentially natural.
Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
Natural mandibular front teeth and first premolars (4-4) are retained.
Second mandibular molars are ideally present to serve as abutment teeth.
Mandibular restorations and/or reconstructions must be in clinically good condition.
Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
Willingness to give their informed consent and comply with the protocol.
No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Exclusion Criteria:
Current participation in other dental clinical trials.
Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
Subjects taking drugs known to currently affect salivary flow.
Subjects with un-stimulated salivary flow <0.3 ml/min and/or stimulated flow <0.9 ml/min.
Women who are pregnant or breastfeeding
History of allergy to common dentifrice ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
Medical condition which requires premedication prior to dental procedures/visits
History of allergy to amino acids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Imfeld, MBA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich, Dental Institute Dept. of Preventive
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
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Effect on Bacterial Glycolytic Acid Formation on Plaque
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