Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

Phase 2

Completed

• Conditions: Dentin Hypersensitivity
• Interventions: Drug: Resin-modified glass ionomer cement Clinpro XT; Drug: Glass Ionomer cement Vidrion R

• Registration Number: NCT02378129
• Lead Sponsor: Federal University of Pelotas

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.

Study Timeline

• Study Start: 2014-04-02
• Study First Submitted: 2015-02-22
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Primary Completion: 2015-04-01
• Study Completion: 2015-04-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinpro XT (3M ESPE, Minnesota, USA)	Resin-modified glass ionomer cement Clinpro XT	Resin-modified glass ionomer cement
Vidrion R (SS White, Gloucester, UK)	Glass Ionomer cement Vidrion R	Conventional glass ionomer cement

Primary Outcome Measures

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