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N/A N=39 Randomized Single-blind Treatment

Caries Prevention Products & Dentinal Hypersensitivity

Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT02136576 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Dentinal Hypersensitivity — 1; 1; 0; 3 units on a scale — p=0.72

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Sensodyne (Device); Crest Cavity Protection & MI Paste Plus (Device); Clinpro 5000 (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tufts University
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Dentinal Hypersensitivity		 1; 1; 0; 3; 2; 2 0.72

Summary

The aim of this pilot research project is to compare the clinical effect on dentinal hypersensitivity of three products: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) paste with fluoride, 5000 Sodium Fluoride (NaF) dentifrice containing Tri-Calcium Phosphate (TCP), and a dentifrice containing Potassium Nitrate. The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will exhibit a greater reduction in dentinal hypersensitivity compared to the control (dentifrice containing Potassium Nitrate). The results of this pilot study will validate or negate the need for a larger clinical study that may provide generalizable results for using caries-prevention products with the additional benefit of minimizing dentinal hypersensitivity.

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age
  • Tooth with exposed root surface and/or exposed dentin
  • Tooth with a VAS score greater than or equal to 3
  • No adjacent tooth/teeth with sensitivity (as defined as 2 or higher on the VAS)

Exclusion Criteria

  • Participation in another dental study that may alter the results of this study.
  • A medical condition that could interfere with reliable pain reporting (e.g., pain disorders)
  • Any chronic medical condition that requires the regular use of pain or anti-inflammatory medications
  • Used a desensitizing dentifrice within the preceding four weeks
  • Have received an antihypersensitivity treatment (varnish or precipitating solution) of the identified tooth within the preceding four weeks
  • Undergoing active orthodontic treatment.
  • Teeth with carious lesions, buccal vertical cracks in enamel, evidence of irreversible pulpitis (pain lasting more than five seconds after air stimulation)
  • Pregnant/ lactating patients (Clinpro5000 has 5000ppm fluoride and there is a risk of ingesting the product)
  • Patients with Milk Allergy (CPP-ACP is a dairy based product)
  • Patients on Kidney Dialysis (due to the free calcium in CPP-ACP, dialysis patients should be on a diet with limited calcium)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02136576). 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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