Effect on Bacterial Glycolytic Acid Formation on Plaque
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Triclosan, Fluoride; fluoride; Fluoride, triclosan, amino acid
Intervention description: Rinse 3 times daily with assigned toothpaste slurry; Rinse 3 times daily with assigned toothpaste slurry; Rinse 3 times daily with assigned toothpaste slurry
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 72 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

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