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Completed

NCT Number: NCT02378129

Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

28 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resin-modified glass ionomer cement Clinpro XT

Drug

Clinpro XT (3M ESPE, Minnesota, USA)

Other names: Clinpro XT (3M Espe, USA)

Glass Ionomer cement Vidrion R

Drug

Vidrion R (SS White, Gloucester, UK)

Other names: Vidrion R (SS White, Gloucester, UK)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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