Effect on Bacterial Glycolytic Acid Formation on Plaque

NCT ID: NCT00762450

Last Updated: 2012-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-08-31

Brief Summary

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

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A- Positive Control

fluoride/triclosan/copolymer toothpaste

Group Type: ACTIVE_COMPARATOR

Triclosan, Fluoride

Intervention Type: DRUG

Rinse 3 times daily with assigned toothpaste slurry

B - Silica control

fluoride only toothpaste

Group Type: PLACEBO_COMPARATOR

fluoride

Intervention Type: DRUG

Rinse 3 times daily with assigned toothpaste slurry

C- Experimental product

fluoride/triclosan/amino acid toothpaste

Group Type: EXPERIMENTAL

Fluoride, triclosan, amino acid

Intervention Type: DRUG

Rinse 3 times daily with assigned toothpaste slurry

Interventions

Triclosan, Fluoride

Rinse 3 times daily with assigned toothpaste slurry

Intervention Type: DRUG

fluoride

Rinse 3 times daily with assigned toothpaste slurry

Intervention Type: DRUG

Fluoride, triclosan, amino acid

Rinse 3 times daily with assigned toothpaste slurry

Intervention Type: DRUG

Other Intervention Names

Total+ Whitening toothpaste; placebo toothpaste (No triclosan, no amino acid)

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

• Minimum Eligible Age: 72 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Imfeld, MBA

Role: PRINCIPAL_INVESTIGATOR

Locations

University of Zurich, Dental Institute Dept. of Preventive

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

CRO-2008-PLA-01-AM

Identifier Type: -

Identifier Source: org_study_id