Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effectiveness of nanohydroxyapatite (nano-HAP)-containing
      toothpastes and cream to relieve dentin hypersensitivity, comparing it with those of a
      commercial desensitizing dentifrice containing calcium sodium phosphosilicate (Novamin®
      technology) and a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium
      monofluorophosphate (MFP).
    

Detailed description: 
      This is a double-blind, randomized, controlled, parallel group, outpatient clinical trial,
      involving a total of 270 patients diagnosed with dentin hypersensitivity, who will be
      randomly assigned to nine treatment groups of 30 patients each. Males or females of age 18 to
      80 years will be enrolled. The nine groups will be randomly assigned to use one of the nine
      test products: (1) toothpaste containing nano-HAP (high concentration); (2) toothpaste
      containing nano-HAP (low concentration); (3) toothpaste containing nano-HAP and potassium
      nitrate (KNO3); (4) toothpaste containing NovaMin; (5) standard fluoride toothpaste with 1500
      ppm MFP; (6) toothpaste containing nano-HAP (medium concentration); (7) placebo toothpaste;
      (8) cream containing nano-HAP; (9) placebo cream. Subjects will be instructed to use the
      study toothpaste as their sole oral hygiene product for the 8 weeks treatment duration while
      the cream will be applied with a retainer tray for 5 minutes before bed at night. For those
      using toothpastes, subjects will be instructed to brush their teeth twice daily for 2
      minutes, morning and last thing before bed, applying on each occasion a one-inch strip of
      their assigned toothpaste on a wetted commercially available soft-bristled toothbrush. Dentin
      hypersensitivity examination, which will include air blast sensitivity and cold thermal
      sensitivity combined with visual analog scale and Dental Pain Scale, will be conducted at
      baseline, 2, 4, 6, and 8 weeks. Subjects will be screened for adverse effects on every visit,
      and all observed adverse events will be recorded when they occur.
    

Intervention name(s): Control toothpaste containing Novamin® technology; Control toothpaste containing 1500 ppm fluoride as MFP; Test toothpaste with nano-HAP (high concentration); Test toothpaste with nano-HAP (low concentration); Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3; Control toothpaste without nano-HAP; Test toothpaste with nano-HAP (medium concentration); Test cream with nano-HAP (higher concentration); Control cream without nano-HAP
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentin hypersensitivity; nanohydroxyapatite; calcium sodium phosphosilicate; toothpaste; tooth cream