search
Back to results

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
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
September 26, 2008
Last Updated
March 5, 2012
Sponsor
Colgate Palmolive
search

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
No

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
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.
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
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

Learn more about this trial

Effect on Bacterial Glycolytic Acid Formation on Plaque

We'll reach out to this number within 24 hrs