Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique

Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique: A Randomized Controlled Trial

Dimethyl sulfoxide (DMSO) wet bonding has shown promising results in several in vitro studies. However, there are a lack of clinical trials which prove the advantages of this technique. The aim of the study is to clinically assess the effect of DMSO wet bonding on composite restoration in non carious cervical lesions.

Study Overview

• Status: Not yet recruiting
• Conditions: Dimethyl Sulfoxide
• Intervention / Treatment: Other: Universal single bond adhesive; Other: DMSO

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anchu Rachel Thomas; Phone Number: 1-700-811-662; Email: rachel.thomas@manipal.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Two similar non carious cervical lesions (NCCLs) on the facial/labial surfaces of premolars.
• NCCLs of score 1-3 on the Smith and Knight tooth wear index.
• Favorable occlusion and teeth are in normal contact.

Exclusion Criteria:

• NCCLs on the lingual surface.
• Medically compromised individuals.
• Periodontally compromised teeth.
• Bruxism and visible wear facets in the posterior dentition.
• Fractured or visibly cracked premolars and canines.
• Known allergies to resin-based restorative materials.
• Presently undergoing orthodontic treatment.
• Abutment teeth for fixed or removable prostheses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Universal single bond adhesive	Other: Universal single bond adhesive; Will be applied and light cured for 20 seconds.
Experimental: DMSO application before Universal single bond adhesive	Other: Universal single bond adhesive; Will be applied and light cured for 20 seconds.; Other: DMSO; DMSO application on tooth followed by active application of universal single bond adhesive and light cured for 20 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture of material	Different fracture patterns and retention failures may occur in relation to the type of restoration: cracks, chipping/ delamination, bulk fractures, or incomplete and complete loss of retention. Assessed by Visual examination and short air drying. Criteria set from Clinically excellent/very good(sufficient) (Score 1) to Clinically poor (entirely insufficient)(Score 5)	From treatment to 3-6 months follow up
Marginal adaptation	There are different interfaces between the dental hard tissue, restorative material, and adhesive and/or luting resin/cement layer. Each interface can degrade and potentially alter marginal adaptation. In clinical practice, it is impossible to distinguish failures between the different interfaces. Therefore, only the marginal adaptation as such can be assessed by visual examination and short air drying. Scores given depending upon the quality of restoration from Clinically excellent/very good (sufficient) (Score 1) to Clinically poor (entirely insufficient) (Score 5)	From treatment to 3-6 months follow up

Collaborators and Investigators

• Sponsor: Manipal University College Malaysia

Publications and helpful links

General Publications

• Lopez-Frias FJ, Castellanos-Cosano L, Martin-Gonzalez J, Llamas-Carreras JM, Segura-Egea JJ. Clinical measurement of tooth wear: Tooth wear indices. J Clin Exp Dent. 2012 Feb 1;4(1):e48-53. doi: 10.4317/jced.50592. eCollection 2012 Feb.
• Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12. Erratum In: Clin Oral Investig. 2023 Jun;27(6):2593. doi: 10.1007/s00784-022-04851-w.

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 049/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No