Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

NCT02378129 | Completed Phase 2

• 1 other identifier: UFPel
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dentin Hypersensitivity

Keywords

Dentin Sensitivity; Dentin Desensitizing Agents; Glass Ionomer Cements; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Pain Scores as measured by the Visual Analog Scale (VAS)

  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.

Study Arms (2)

Clinpro XT (3M ESPE, Minnesota, USA)

EXPERIMENTAL

Resin-modified glass ionomer cement

Drug: Resin-modified glass ionomer cement Clinpro XT

Vidrion R (SS White, Gloucester, UK)

ACTIVE COMPARATOR

Conventional glass ionomer cement

Drug: Glass Ionomer cement Vidrion R

Interventions

Resin-modified glass ionomer cement Clinpro XT DRUG

Clinpro XT (3M ESPE, Minnesota, USA)

Also known as: Clinpro XT (3M Espe, USA)

Clinpro XT (3M ESPE, Minnesota, USA)

Glass Ionomer cement Vidrion R DRUG

Vidrion R (SS White, Gloucester, UK)

Also known as: Vidrion R (SS White, Gloucester, UK)

Vidrion R (SS White, Gloucester, UK)

Eligibility Criteria

• Age: 28 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Related Publications (6)

• 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.

  PMID: 24180588 BACKGROUND

• 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.

  PMID: 5228880 BACKGROUND

• 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.

  PMID: 23616976 BACKGROUND

• 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.

  PMID: 22882712 BACKGROUND

• 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.

  PMID: 16803826 BACKGROUND

• 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.

  PMID: 28076496 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Vidrion-R

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rafael G Lund, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2015
• First Posted: March 4, 2015
• Study Start: April 2, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share