Overview

This trial is active, not recruiting.

Condition dentin hypersensitivity
Treatments resin-modified glass ionomer cement clinpro xt, glass ionomer cement vidrion r
Phase phase 2/phase 3
Sponsor Federal University of Pelotas
Start date April 2014
End date April 2016
Trial size 20 participants
Trial identifier NCT02378129, UFPel

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Resin-modified glass ionomer cement
resin-modified glass ionomer cement clinpro xt Clinpro XT (3M Espe, USA)
Clinpro XT (3M ESPE, Minnesota, USA)
(Active Comparator)
Conventional glass ionomer cement
glass ionomer cement vidrion r Vidrion R (SS White, Gloucester, UK)
Vidrion R (SS White, Gloucester, UK)

Primary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 28 years up to 70 years old.

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

Additional Information

Official title Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial
Principal investigator Rafael G Lund, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Federal University of Pelotas.