Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

NCT ID: NCT02378129

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-02

Study Completion Date

2015-04-01

Brief Summary

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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

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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.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Clinpro XT (3M ESPE, Minnesota, USA)

Resin-modified glass ionomer cement

Group Type EXPERIMENTAL

Resin-modified glass ionomer cement Clinpro XT

Intervention Type DRUG

Clinpro XT (3M ESPE, Minnesota, USA)

Vidrion R (SS White, Gloucester, UK)

Conventional glass ionomer cement

Group Type ACTIVE_COMPARATOR

Glass Ionomer cement Vidrion R

Intervention Type DRUG

Vidrion R (SS White, Gloucester, UK)

Interventions

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Resin-modified glass ionomer cement Clinpro XT

Clinpro XT (3M ESPE, Minnesota, USA)

Intervention Type DRUG

Glass Ionomer cement Vidrion R

Vidrion R (SS White, Gloucester, UK)

Intervention Type DRUG

Other Intervention Names

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Clinpro XT (3M Espe, USA) Vidrion R (SS White, Gloucester, UK)

Eligibility Criteria

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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
Minimum Eligible Age

28 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Rafael Guerra Lund

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael G Lund, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

References

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Lund RG, Silva AF, Piva E, Da Rosa WL, Heckmann SS, Demarco FF. Clinical evaluation of two desensitizing treatments in southern Brazil: A 3-month follow-up. Acta Odontol Scand. 2013 Nov;71(6):1469-74. doi: 10.3109/00016357.2013.770919. Epub 2013 Jul 3.

Reference Type BACKGROUND
PMID: 24180588 (View on PubMed)

Brannstrom M. The hydrodynamics of the dental tubule and pulp fluid: its significance in relation to dentinal sensitivity. Annu Meet Am Inst Oral Biol. 1966;23:219. No abstract available.

Reference Type BACKGROUND
PMID: 5228880 (View on PubMed)

da Rosa WL, Lund RG, Piva E, da Silva AF. The effectiveness of current dentin desensitizing agents used to treat dental hypersensitivity: a systematic review. Quintessence Int. 2013 Jul;44(7):535-46. doi: 10.3290/j.qi.a29610.

Reference Type BACKGROUND
PMID: 23616976 (View on PubMed)

Que K, Guo B, Jia Z, Chen Z, Yang J, Gao P. A cross-sectional study: non-carious cervical lesions, cervical dentine hypersensitivity and related risk factors. J Oral Rehabil. 2013 Jan;40(1):24-32. doi: 10.1111/j.1365-2842.2012.02342.x. Epub 2012 Aug 7.

Reference Type BACKGROUND
PMID: 22882712 (View on PubMed)

Orchardson R, Gillam DG. Managing dentin hypersensitivity. J Am Dent Assoc. 2006 Jul;137(7):990-8; quiz 1028-9. doi: 10.14219/jada.archive.2006.0321.

Reference Type BACKGROUND
PMID: 16803826 (View on PubMed)

Madruga MM, Silva AF, Rosa WL, Piva E, Lund RG. Evaluation of dentin hypersensitivity treatment with glass ionomer cements: A randomized clinical trial. Braz Oral Res. 2017 Jan 5;31:e3. doi: 10.1590/1807-3107BOR-2017.vol31.0003.

Reference Type BACKGROUND
PMID: 28076496 (View on PubMed)

Other Identifiers

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UFPel

Identifier Type: -

Identifier Source: org_study_id

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