Caries Prevention Products & Dentinal Hypersensitivity
Completed · Not applicable
Conditions studied: Hypersensitivity
In brief
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.
Key facts
- Study ID
- NCT02136576
- Run by
- Tufts University
- People needed
- 39
- Starts
- 2014-05-01
- Expected to finish
- 2018-10-01
- Last updated by the study team
- 2020-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.