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Effect on Bacterial Glycolytic Acid Formation on Plaque

Primary Purpose

Dental Plaque

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Triclosan, Fluoride

fluoride

Fluoride, triclosan, amino acid

About this trial

This is an interventional treatment trial for Dental Plaque

Eligibility Criteria

72 Years - 79 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Zurich, Dental Institute Dept. of Preventive

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

A- Positive Control

B - Silica control

C- Experimental product

Arm Description

fluoride/triclosan/copolymer toothpaste

fluoride only toothpaste

fluoride/triclosan/amino acid toothpaste

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00762450

First Posted

September 26, 2008

Last Updated

March 5, 2012

Sponsor

Colgate Palmolive

1. Study Identification

Unique Protocol Identification Number

NCT00762450

Brief Title

Effect on Bacterial Glycolytic Acid Formation on Plaque

Official Title

Effect on Bacterial Glycolytic Acid Formation on Plaque

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Colgate Palmolive

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Plaque

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A- Positive Control

Arm Type

Active Comparator

Arm Description

fluoride/triclosan/copolymer toothpaste

Arm Title

B - Silica control

Arm Type

Placebo Comparator

Arm Description

fluoride only toothpaste

Arm Title

C- Experimental product

Arm Type

Experimental

Arm Description

fluoride/triclosan/amino acid toothpaste

Intervention Type

Drug

Intervention Name(s)

Triclosan, Fluoride

Other Intervention Name(s)

Total+ Whitening toothpaste

Intervention Description

Rinse 3 times daily with assigned toothpaste slurry

Intervention Type

Drug

Intervention Name(s)

fluoride

Other Intervention Name(s)

placebo toothpaste (No triclosan, no amino acid)

Intervention Description

Rinse 3 times daily with assigned toothpaste slurry

Intervention Type

Drug

Intervention Name(s)

Fluoride, triclosan, amino acid

Intervention Description

Rinse 3 times daily with assigned toothpaste slurry

Primary Outcome Measure Information:

Title

ph of Dental Plaque After Sucrose Challenge

Description

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

72 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Imfeld, MBA

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Zurich, Dental Institute Dept. of Preventive

City

Zurich

Country

Switzerland

12. IPD Sharing Statement

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Effect on Bacterial Glycolytic Acid Formation on Plaque

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