Phase 3
N=6
Effect on Bacterial Glycolytic Acid Formation on Plaque
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT00762450 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: ph of Dental Plaque After Sucrose Challenge — 4.88; 5.04; 4.98 ph of dental plaque — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan, Fluoride (Drug); fluoride (Drug); Fluoride, triclosan, amino acid (Drug)
- Age
- Older Adult · 72+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ph of Dental Plaque After Sucrose Challenge |
4.88; 5.04; 4.98 | 0.05 |
Summary
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental 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
Data sourced from ClinicalTrials.gov (NCT00762450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.