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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

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE December 14, 2010
Results First Posted Date  ICMJE February 15, 2011
Last Update Posted Date March 7, 2012
Study Start Date  ICMJE April 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Dental plaque [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT00762450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect on Bacterial Glycolytic Acid Formation on Plaque
Official Title  ICMJE Effect on Bacterial Glycolytic Acid Formation on Plaque
Brief Summary To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dental Plaque
Intervention  ICMJE
  • Drug: Triclosan, Fluoride
    Rinse 3 times daily with assigned toothpaste slurry
    Other Name: Total+ Whitening toothpaste
  • Drug: fluoride
    Rinse 3 times daily with assigned toothpaste slurry
    Other Name: placebo toothpaste (No triclosan, no amino acid)
  • Drug: Fluoride, triclosan, amino acid
    Rinse 3 times daily with assigned toothpaste slurry
Study Arms  ICMJE
  • Active Comparator: A- Positive Control
    fluoride/triclosan/copolymer toothpaste
    Intervention: Drug: Triclosan, Fluoride
  • Placebo Comparator: B - Silica control
    fluoride only toothpaste
    Intervention: Drug: fluoride
  • Experimental: C- Experimental product
    fluoride/triclosan/amino acid toothpaste
    Intervention: Drug: Fluoride, triclosan, amino acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 72 Years to 79 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762450
Other Study ID Numbers  ICMJE CRO-2008-PLA-01-AM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colgate Palmolive
Study Sponsor  ICMJE Colgate Palmolive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Imfeld, MBA
PRS Account Colgate Palmolive
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP