Effect on Bacterial Glycolytic Acid Formation on Plaque

NCT00762450 | Completed Phase 3 Results

• 1 other identifier: CRO-2008-PLA-01-AM
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

A- Positive Control

ACTIVE COMPARATOR

fluoride/triclosan/copolymer toothpaste

Drug: Triclosan, Fluoride

B - Silica control

PLACEBO COMPARATOR

fluoride only toothpaste

Drug: fluoride

C- Experimental product

EXPERIMENTAL

fluoride/triclosan/amino acid toothpaste

Drug: Fluoride, triclosan, amino acid

Interventions

Triclosan, Fluoride DRUG

Rinse 3 times daily with assigned toothpaste slurry

Also known as: Total+ Whitening toothpaste

A- Positive Control

fluoride DRUG

Rinse 3 times daily with assigned toothpaste slurry

Also known as: placebo toothpaste (No triclosan, no amino acid)

B - Silica control

Fluoride, triclosan, amino acid DRUG

Rinse 3 times daily with assigned toothpaste slurry

C- Experimental product

Eligibility Criteria

• Age: 72 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

University of Zurich, Dental Institute Dept. of Preventive

Zurich, Switzerland

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Triclosan; Fluorides; hydrated silica gel-based toothpaste; Amino Acids

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: William De Vizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Thomas Imfeld, MBA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 7, 2012
• Results First Posted: February 15, 2011

Record last verified: 2012-03

Locations

CH (1)