Clinical Trial: Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream

Brief 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 Summary: 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.
Sponsor: The University of Texas Health Science Center at San Antonio

Current Primary Outcome:

  • Change in VAS with air stimulation [ Time Frame: Baseline to 2, 4, 6, 8 weeks ]
    Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-10
  • Change in VAS with cold stimulation [ Time Frame: Baseline to 2, 4, 6, 8 weeks ]
    Patient's response to cold stimulus is recorded on a Visual Analog Scale of 0-10
  • Change in DPS with air stimulation [ Time Frame: Baseline to 2, 4, 6, 8 weeks ]
    Patient's response to an air stimulus is recorded on a Dental Pain Scale (none-mild-moderate-severe).
  • Change in DPS with cold stimulation [ Time Frame: Baseline to 2, 4, 6, 8 weeks ]
    Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none-mild-moderate-severe).


Original Primary Outcome: Same as current

Current Secondary Outcome: Observed adverse events [ Time Frame: Baseline to 8 weeks ]

Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center at San Antonio

Dates:
Date Received: September 13, 2016
Date Started: May 2015
Date Completion:
Last Updated: March 28, 2017
Last Verified: March 2017