Evaluation of Dentin Hypersensitivity Using Glass Ionomer Cements

Dentin Hypersensitivity Clinical Trial

Official title:

Evaluation of the Effectiveness of Dentin Hypersensitivity Treatment Using Glass Ionomer Cements: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378129
• Other study ID #: UFPel
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2, 2014
• Est. completion date: April 1, 2015

Study information

• Verified date: August 2020
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• Resin-modified glass ionomer cement Clinpro XT
Clinpro XT (3M ESPE, Minnesota, USA)
• Glass Ionomer cement Vidrion R
Vidrion R (SS White, Gloucester, UK)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

References & Publications (6)

Brännström 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. — View 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. Review. — View 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. — View 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. — View Citation

Orchardson R, Gillam DG. Managing dentin hypersensitivity. J Am Dent Assoc. 2006 Jul;137(7):990-8; quiz 1028-9. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.