Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment

NCT04492306 | Completed DMC

• 1 other identifier: DMSO Clinical Trial
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in order to evaluate the clinical effectiveness of 1% DMSO dentin pre-treatment on the clinical performance of etch and rinse adhesive.

Conditions

Dental Diseases

Keywords

DMSO

Outcome Measures

Primary Outcomes (1)

• Biological (change of caries adjacent to the restoration)

  FDI criteria for evaluation of restorations, percentage score. * Score: Properties * Clinically excellent/ very good: No secondary or primary caries. * Clinically good: Small and Localized 1. Demineralization, 2. Erosion or 3. Abfraction. * Clinically sufficient/satisfactory: Larger areas Of 1. Demineralization, 2. Erosion or 3. Abrasion/abfraction, dentine not exposed. * Clinically unsatisfactory: Caries with Cavitation and suspected undermining caries, 2. Erosion in dentine, 3. Abrasion/ abfraction in dentine. * Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration.

  Day 0, Month 6, Month 12, Month 18

Secondary Outcomes (1)

• Functional (change of marginal adaptation)

  Day 0, Month 6, Month 12, Month 18

Other Outcomes (1)

• Esthetic (Color match and translucency)

  Day 0, Month 6, Month 12, Month 18

Study Arms (2)

3M single bond, etch and rinse adhesive

ACTIVE COMPARATOR

O.I. will clean the labial surface of tooth with polishing paste and brush Roughening of the surface may be needed by diamond point The tooth will be isolated by rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 10 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Apply 2 to 3 consecutive coats of the adhesive for 15 s. Gently air for 5 s. Light cure for 10 s. Composite build ups (Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) were performed in increments and individually light-cured for 40 s. Light curing of all resin materials was performed using a LED device (Bluephase 20i, Ivoclare Vivadent, Schaan, Liechtenstein) delivering 1100 mW/cm2.

Other: 3M ESPE Single bond 2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch

DMSO pre-treatment before 3M single bond application

EXPERIMENTAL

The same steps of the comparator group with additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 1% DMSO/H2O solutions on etched-dentin followed by blot drying until paper filters no longer absorbed liquids from the bonding surface by capillarity then apply adhesive.

Other: Dimethyl Sulfoxide; Other: 3M ESPE Single bond 2; Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA); Other: 3m ESPE etch

Interventions

Dimethyl Sulfoxide OTHER

DMSO \[(CH3)2SO\] is a polar aprotic solvent that dissolves both polar and non-polar compounds.

Also known as: 1% DMSO

DMSO pre-treatment before 3M single bond application

3M ESPE Single bond 2 OTHER

Total etch adhesive bond

3M single bond, etch and rinse adhesive; DMSO pre-treatment before 3M single bond application

Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) OTHER

Composite Resin

3M single bond, etch and rinse adhesive; DMSO pre-treatment before 3M single bond application

3m ESPE etch OTHER

32% phosphoric acid

3M single bond, etch and rinse adhesive; DMSO pre-treatment before 3M single bond application

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with cervical lesions.
• Co-operative patients approving to participate in the study.
• Pulp is asymptomatic vital teeth.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

• Xerostomia.
• Bruxism and visible wear facets in the posterior dentition.
• Known inability to return for recall appointments.
• Fractured or visibly cracked candidate tooth.
• Current desensitizing therapy, including desensitizing dentifrices or other over-the-counter (OTC) products.
• Long-term use of anti-inflammatory, analgesic, or psychotropic drugs.
• Pregnancy or breastfeeding (potential conflicts with recall dates.
• Allergies to ingredients of resin-based restorative materials.
• Orthodontic appliance treatment within the previous three months.
• Abutment teeth for fixed or removable prostheses.
• Teeth or supporting structures with any symptomatic pathology.
• Existing periodontal disease or periodontal surgery within the previous three months.

Sponsors & Collaborators

• Cairo University: lead
• University of Turku: collaborator

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Interventions

Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Officials

• Randa Hafez, Professor

  Cairo U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In our clinical trial double blinding will be performed, the participants and both assessors (H.M.\& N.H.) will be blinded to the type of the material used to reduce performance and ascertainment bias and also reduce biased estimates of treatment effects. The operator cannot be blinded in this trial because of the difference in the application procedures of each restorative material. Therefore, the operator (O.I.) will take care to treat the two allocation groups as equally as possible by standardizing the care of participants, frequency of follow-ups and management of complications.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Restorative Dentistry,HUE. Member of the adhesive group of Turku.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 30, 2020
• Study Start: November 17, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

EG (1)