Invivo Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive

NCT ID: NCT05090085

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-02-24

Brief Summary

This study is conducted to assess the clinical effectiveness of 10% Dimethyl Sulfoxide in OT Primer prior to two step etch and rinse dental adhesive on the durability of composite restoration.

Detailed Description

Randomized Controlled Clinical Trial After the power analysis calculation, 74 cervical lesions will be included in this study. Half of them will be pretreated with 10% DMSO/H2O (Dimethyl Sulfoxide/Water, OT Primer, OT Dent). Control groups will be bonded with SB (Single Bond2, 3M ESPE). Cavities will be restored with nanohybrid composite restoration (Z350 XT, 3M ESPE) under rubber dam isolation. Follow-ups will be performed by double-blinded evaluators at baseline and after 6m, 12m, 24m, and 36m using the FDI criteria. Photographic documentation will be performed for all restorations.

Sample size calculation The sample size was calculated based on a previous study by Vural et al in 2020, in which success rate of resin composite cervical restorations was 73% after 36 months. By implementing a two tailed Z test for difference between two independent proportions with an alpha level of 5% and a power of 80%. The minimum sample size needed was 30 per group in order to detect a difference of 25%. Sample size was increased by 25% to compensate for possible dropouts to reach 37 teeth per group. Sample size was performed using G*Power version 3.1.9.2 for windows.

Statistical Analyses Data was analyzed using Medcalc software, version 22 for windows (MedCalc Software Ltd, Ostend, Belgium). Categorical data was described as frequency and percentage, intergroup comparisons between interventions was performed using Chi-Square test with statistical significance level set at (P ≤ 0.05), intragroup comparison within each intervention was performed using the Cochran's Q test with statistical significance level set at (P ≤ 0.0083) after Bonferroni correction. Relative risk was used to assess the clinical significance. Survival rate was analyzed using Kaplan-meier and Log-rank test. The confidence limit was set at 95% with 80% power and all tests were two tailed.

Conditions

Dental Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

3M Adper Single Bond2

O.I. will clean the labial surface of the tooth with polishing paste and brush Roughening of the surface may be needed by the diamond point The tooth will be isolated by a rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 15 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Active application of 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 20 s. Light curing of all resin materials was performed using (3M Elipar Curing Light) delivering 1100 mW/cm2.

Group Type: ACTIVE_COMPARATOR

3M Adper Single Bond2

Intervention Type: OTHER

Two-step etch and rinse dental adhesive system

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

Intervention Type: OTHER

Composite Resin

3m ESPE etch

Intervention Type: OTHER

32% phosphoric acid

DMSO application before 3M Adper Single Bond2, etch and rinse adhesive

The same steps of the comparator group with an additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 10% DMSO/H2O (OT Primer, OT Dent) solutions on etched-dentin for 1 minute followed by 20 seconds of air drying then apply adhesive.

Group Type: EXPERIMENTAL

3M Adper Single Bond2

Intervention Type: OTHER

Two-step etch and rinse dental adhesive system

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

Intervention Type: OTHER

Composite Resin

3m ESPE etch

Intervention Type: OTHER

32% phosphoric acid

OT Primer

Intervention Type: OTHER

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

Interventions

3M Adper Single Bond2

Two-step etch and rinse dental adhesive system

Intervention Type: OTHER

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

Composite Resin

Intervention Type: OTHER

3m ESPE etch

32% phosphoric acid

Intervention Type: OTHER

OT Primer

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

Intervention Type: OTHER

Other Intervention Names

10% DMSO/H2O

Eligibility Criteria

Inclusion Criteria

• Patients with Carious Cervical Lesions (CCL).
• Co-operative patients approved to participate in the study.
• Pulp is asymptomatic vital teeth.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria

• Patients with Non-Carious Cervical Lesions (NCCL).
• 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 breast-feeding (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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horus University

OTHER

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Omar Abdelaziz Ismail

Principal Investigator, BDS, MSc, FINDOS Candidate Cariology and Restorative Dentistry. Member of the Adhesive group of Turku. Finland

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu Tezvergil-Mutluay, Professor

Role: STUDY_CHAIR

University of Turku

Locations

Horus University in Egypt

Damietta, Damietta Governorate, Egypt

Countries

Egypt

Other Identifiers

UTurku Clinical DMSO

Identifier Type: -

Identifier Source: org_study_id