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Phase 3 N=6 Randomized Double-blind Treatment

Effect on Bacterial Glycolytic Acid Formation on Plaque

Dental Plaque

Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: ph of Dental Plaque After Sucrose Challenge — 4.88; 5.04; 4.98 ph of dental plaque — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Triclosan, Fluoride (Drug); fluoride (Drug); Fluoride, triclosan, amino acid (Drug)
Age
Older Adult · 72+ yrs
Sex
All
Sponsor
Colgate Palmolive
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
ph of Dental Plaque After Sucrose Challenge
4.88; 5.04; 4.98 0.05

Summary

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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00762450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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