Status:
COMPLETED
Effect on Bacterial Glycolytic Acid Formation on Plaque
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Plaque
Eligibility:
All Genders
72-79 years
Phase:
PHASE3
Brief Summary
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00762450
Start Date
April 1 2008
End Date
August 1 2008
Last Update
March 7 2012
Active Locations (1)
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1
University of Zurich, Dental Institute Dept. of Preventive
Zurich, Switzerland