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Clinical Trials/NCT02378129
NCT02378129
Completed
Phase 2

Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial

Federal University of Pelotas0 sites20 target enrollmentApril 2, 2014

Overview

Phase
Phase 2
Intervention
Resin-modified glass ionomer cement Clinpro XT
Conditions
Dentin Hypersensitivity
Sponsor
Federal University of Pelotas
Enrollment
20
Primary Endpoint
Pain Scores as measured by the Visual Analog Scale (VAS)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this randomized, double-blind, split-mouth clinical trial is to evaluate and compare the desensitizing efficacies of the resin-modified glass ionomer cement ClinproTM XT (3M ESPE, Minnesota, USA) and the conventional glass ionomer cement Vidrion R (SS White, Gloucester, UK) at 2-year follow-up.

Detailed Description

Subjects will require to have at least two teeth in different hemiarchs with dentin hypersensitivity. Teeth will be randomized into 2 groups, receiving either Clinpro XT or the conventional glass ionomer cement Vidrion R. Prior to the desensitizing treatment (baseline), painful symptoms will be assessed by tactile and air blast tests using the Visual Analogue Scale (VAS). Treatment evaluations will be conducted up to 2-year post-treatment.

Registry
clinicaltrials.gov
Start Date
April 2, 2014
End Date
April 1, 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Rafael Guerra Lund

Associate Professor

Federal University of Pelotas

Eligibility Criteria

Inclusion Criteria

  • Male and female subjects between 18 and 70 years old
  • At least 2 teeth with dentin hypersensitivity in two different hemiarchs
  • Dental elements with hypersensitivity without any pulp alteration
  • People who are not taking any medication and women who are not pregnant
  • Patients without eating disorders or very acidic diets.

Exclusion Criteria

  • Teeth with hypersensitivity that presented extensive or unsatisfactory restorations, fractures, periodontal alterations, caries lesions, orthodontic brackets, endodontic treatments, pulp alterations.
  • Subjects who received any desensitizing therapy during the last 3 months
  • Subjects being under analgesics/anti-inflammatory drugs at the time of the study
  • Teeth with hypersensitivity and non-carious cervical lesions

Arms & Interventions

Clinpro XT (3M ESPE, Minnesota, USA)

Resin-modified glass ionomer cement

Intervention: Resin-modified glass ionomer cement Clinpro XT

Vidrion R (SS White, Gloucester, UK)

Conventional glass ionomer cement

Intervention: Glass Ionomer cement Vidrion R

Outcomes

Primary Outcomes

Pain Scores as measured by the Visual Analog Scale (VAS)

Time Frame: Change from Baseline in Pain Scores at 20 minutes; at 7, 15, 21, 30 days; and after 3, 6, 12, 24 months.

Tactile and air blast tests to evaluate pain with VAS

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