NCT05090085

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

Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	3M Adper Single Bond2	Two-step etch and rinse dental adhesive system
OTHER	Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)	Composite Resin
OTHER	3m ESPE etch	32% phosphoric acid
OTHER	OT Primer	Dimethyl Sulfoxide DMSO \[(CH3)2SO\] is a polar aprotic solvent that dissolves both polar and non-polar compounds.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2025-02-24
• First posted: 2021-10-22
• Last updated: 2025-04-24

Locations

1 site across 1 country: Egypt