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| Name | Class |
|---|---|
| Horus University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M Adper Single Bond2 | Active Comparator | 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. |
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| DMSO application before 3M Adper Single Bond2, etch and rinse adhesive | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M Adper Single Bond2 | Other | Two-step etch and rinse dental adhesive system |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional (Number of Restorations with change of marginal adaptation) | FDI criteria for evaluation of restorations, percentage score.
| [Time Frame: Day 0, Month 12, Month 24, Month 36] |
| Measure | Description | Time Frame |
|---|---|---|
| Esthetic (Number of Restorations with change of color match and translucency) | FDI criteria for evaluation of restorations, percentage score.
more translucent ,3. darker,4. brighter.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arzu Tezvergil-Mutluay, Professor | University of Turku | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horus University in Egypt | Damietta | Damietta Governorate | Egypt |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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In our clinical trial, double blinding will be performed, the participants and assessors will be blinded to the type of 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.
| Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) | Other | Composite Resin |
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| 3m ESPE etch | Other | 32% phosphoric acid |
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| OT Primer | Other | Dimethyl Sulfoxide DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. |
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| [Time Frame: Day 0, Month 12, Month 24, Month 36] |
| Biological (Number of Restorations with change of caries adjacent to the restoration) | FDI criteria for evaluation of restorations, percentage score.
Abrasion/ abfraction in dentine. • Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration. | [Time Frame: Day 0, Month 12, Month 24, Month 36] |