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Effect on Bacterial Glycolytic Acid Formation on Plaque

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00762450
First received: September 26, 2008
Last updated: March 5, 2012
Last verified: March 2012
History of Changes

September 26, 2008
March 5, 2012
April 2008
August 2008   (final data collection date for primary outcome measure)
ph of Dental Plaque After Sucrose Challenge [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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.
Dental plaque [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00762450 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Effect on Bacterial Glycolytic Acid Formation on Plaque
Effect on Bacterial Glycolytic Acid Formation on Plaque

To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Plaque
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
72 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00762450
CRO-2008-PLA-01-AM
No
Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Thomas Imfeld, MBA
Colgate Palmolive
March 2012

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