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Effect on Bacterial Glycolytic Acid Formation on Plaque

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ClinicalTrials.gov Identifier: NCT00762450
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : February 15, 2011
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Description
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Brief Summary:
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.

Condition or disease Intervention/treatment Phase
Dental Plaque Drug: Triclosan, Fluoride Drug: fluoride Drug: Fluoride, triclosan, amino acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect on Bacterial Glycolytic Acid Formation on Plaque
Study Start Date : April 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A- Positive Control
fluoride/triclosan/copolymer toothpaste
 Drug: Triclosan, Fluoride
Rinse 3 times daily with assigned toothpaste slurry
Other Name: Total+ Whitening toothpaste
Placebo Comparator: B - Silica control
fluoride only toothpaste
 Drug: fluoride
Rinse 3 times daily with assigned toothpaste slurry
Other Name: placebo toothpaste (No triclosan, no amino acid)
Experimental: C- Experimental product
fluoride/triclosan/amino acid toothpaste
 Drug: Fluoride, triclosan, amino acid
Rinse 3 times daily with assigned toothpaste slurry


Outcome Measures
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Primary Outcome Measures :
  1. ph of Dental Plaque After Sucrose Challenge [ Time Frame: 1 week ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   72 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762450


Locations
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Switzerland
University of Zurich, Dental Institute Dept. of Preventive
Zurich, Switzerland
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Thomas Imfeld, MBA
More Information
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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762450    
Other Study ID Numbers: CRO-2008-PLA-01-AM
First Posted: September 30, 2008    Key Record Dates
Results First Posted: February 15, 2011
Last Update Posted: March 7, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Triclosan
Fluorides
Cariostatic Agents
Protective Agents
 Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents