Effect on Bacterial Glycolytic Acid Formation on Plaque

Dental Plaque Clinical Trial

Official title:

Effect on Bacterial Glycolytic Acid Formation on Plaque

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762450
• Other study ID #: CRO-2008-PLA-01-AM
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: March 5, 2012
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: March 2012
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 72 Years to 79 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Drug:
• Triclosan, Fluoride
Rinse 3 times daily with assigned toothpaste slurry
• fluoride
Rinse 3 times daily with assigned toothpaste slurry
• Fluoride, triclosan, amino acid
Rinse 3 times daily with assigned toothpaste slurry

Locations

Country	Name	City	State
Switzerland	University of Zurich, Dental Institute Dept. of Preventive	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ph of Dental Plaque After Sucrose Challenge	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.	1 week	No