Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

August 13, 2020 updated by: Rafael Guerra Lund, Federal University of Pelotas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinpro XT (3M ESPE, Minnesota, USA)
Resin-modified glass ionomer cement
Drug: Resin-modified glass ionomer cement Clinpro XT
Clinpro XT (3M ESPE, Minnesota, USA)
Other Names:
  • Clinpro XT (3M Espe, USA)
Active Comparator: Vidrion R (SS White, Gloucester, UK)
Conventional glass ionomer cement
Drug: Glass Ionomer cement Vidrion R
Vidrion R (SS White, Gloucester, UK)
Other Names:
  • Vidrion R (SS White, Gloucester, UK)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Pelotas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 22, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After completing the study, the 20 volunteers continued to be served sporadically at the regular dentistry service of the Faculty of Dentistry of Pelotas, Federal University of Pelotas (UFPel).

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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