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Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Resin-modified glass ionomer cement Clinpro XT
Glass Ionomer cement Vidrion R
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin Sensitivity, Dentin Desensitizing Agents, Glass Ionomer Cements, Randomized Controlled Trial

Eligibility Criteria

28 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Clinpro XT (3M ESPE, Minnesota, USA)

    Vidrion R (SS White, Gloucester, UK)

    Arm Description

    Resin-modified glass ionomer cement

    Conventional glass ionomer cement

    Outcomes

    Primary Outcome Measures

    Pain Scores as measured by the Visual Analog Scale (VAS)
    Tactile and air blast tests to evaluate pain with VAS

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2015
    Last Updated
    August 13, 2020
    Sponsor
    Federal University of Pelotas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02378129
    Brief Title
    Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements
    Official Title
    Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2, 2014 (Actual)
    Primary Completion Date
    April 1, 2015 (Actual)
    Study Completion Date
    April 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Pelotas

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dentin Hypersensitivity
    Keywords
    Dentin Sensitivity, Dentin Desensitizing Agents, Glass Ionomer Cements, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinpro XT (3M ESPE, Minnesota, USA)
    Arm Type
    Experimental
    Arm Description
    Resin-modified glass ionomer cement
    Arm Title
    Vidrion R (SS White, Gloucester, UK)
    Arm Type
    Active Comparator
    Arm Description
    Conventional glass ionomer cement
    Intervention Type
    Drug
    Intervention Name(s)
    Resin-modified glass ionomer cement Clinpro XT
    Other Intervention Name(s)
    Clinpro XT (3M Espe, USA)
    Intervention Description
    Clinpro XT (3M ESPE, Minnesota, USA)
    Intervention Type
    Drug
    Intervention Name(s)
    Glass Ionomer cement Vidrion R
    Other Intervention Name(s)
    Vidrion R (SS White, Gloucester, UK)
    Intervention Description
    Vidrion R (SS White, Gloucester, UK)
    Primary Outcome Measure Information:
    Title
    Pain Scores as measured by the Visual Analog Scale (VAS)
    Description
    Tactile and air blast tests to evaluate pain with 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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rafael G Lund, PhD
    Organizational Affiliation
    Federal University of Pelotas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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).
    Citations:
    PubMed Identifier
    24180588
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    5228880
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23616976
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22882712
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16803826
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28076496
    Citation
    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.
    Results Reference
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    Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

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