Effect on Bacterial Glycolytic Acid Formation on Plaque

Phase 3

Completed

Interventions: Drug: Triclosan, Fluoride
Drug: fluoride
Drug: Fluoride, triclosan, amino acid

Brief Summary: To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A- Positive Control	Triclosan, Fluoride	fluoride/triclosan/copolymer toothpaste
B - Silica control	fluoride	fluoride only toothpaste
C- Experimental product	Fluoride, triclosan, amino acid	fluoride/triclosan/amino acid toothpaste

Primary Outcome Measures

Name	Time	Method
ph of Dental Plaque After Sucrose Challenge	1 week	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