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

Study Overview
=================
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 power analysis calculation, cervical lesions 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, 18m and 24m using the FDI criteria. Photographic documentation will be performed for all restorations. Sample size calculation In a previous study response within each subject per group was normally distributed. If the true difference in the experimental and control means is 20%, the investigators will need to study 31 subjects per group (62 subjects) to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The sample size was increased by 15% to compensate for dropouts to reach a total of 74 (37 per group). The Type I error probability associated with this test of this null hypothesis is 0.05. The sample size had been calculated using the Z test (difference between two independent proportions). Statistical Analyses After confirming the normality, Shapiro-Wilk test, and the homoscedasticity of the data, Barlett test, ANOVA will be used. Differences between groups were calculated using Tukey's post hoc test (α=0.05). Statistical analysis will be performed with IBM SPSS Statistical Package for the Social Sciences statistical Version 25 for Windows.

Official Title
-----------------
Invivo Clinical Assessment of Dimethyl Sulfoxide in OT Primer Prior to Dental Adhesive: Randomized Control Trial

Conditions
-----------------
Dental Diseases

Intervention / Treatment
-----------------
* Other: 3M Adper Single Bond2
* Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
* Other: 3m ESPE etch
* Other: OT Primer


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3M Adper Single Bond2<br>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. | Other: 3M Adper Single Bond2<br>* Two-step etch and rinse dental adhesive system<br>Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)<br>* Composite Resin<br>Other: 3m ESPE etch<br>* 32% phosphoric acid<br>|
| Experimental: DMSO application before 3M Adper Single Bond2, etch and rinse adhesive<br>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. | Other: 3M Adper Single Bond2<br>* Two-step etch and rinse dental adhesive system<br>Other: Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)<br>* Composite Resin<br>Other: 3m ESPE etch<br>* 32% phosphoric acid<br>Other: OT Primer<br>* Dimethyl Sulfoxide DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds.<br>* Other names: 10% DMSO/H2O;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional (Number of Restorations with change of marginal adaptation) | FDI criteria for evaluation of restorations, percentage score. Score: Properties. Clinically excellent/ very good: Harmonious outline, no gaps, no white or discolored lines. Clinically good: Marginal gap (<150 μm), White lines. Or Small marginal fracture removable by polishing. or Slight ditching, slight step/flashes, minor Irregularities. Clinically sufficient/satisfactory: Gap < 250 μm not removable. Or Several small marginal fractures. Or Major irregularities, ditching or flash, steps. Clinically unsatisfactory: Gap > 250 μm or dentine/base exposed. Or Severe ditching or marginal fractures. or Larger irregularities or steps (repair necessary). Clinically poor: Restoration (complete or partial) is loose but in situ. Or Generalized major gaps or irregularities. | [Time Frame: Day 0, Month 6, Month 12, Month 18, Month24] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic (Number of Restorations with change of color match and translucency) | FDI criteria for evaluation of restorations, percentage score. Score: Properties Clinically excellent/ very good: Good color match, no difference in shade and/or translucency. Clinically good: Minor deviations in shade and/or translucency. Clinically sufficient/satisfactory: Distinct deviation but acceptable. Does not affect esthetics: 1. more opaque ,2. more translucent ,3. darker,4. brighter. Clinically unsatisfactory: Localized clinically deviation that can be corrected by repair: 1.Too opaque, 2.Too translucent,3. Too dark, 4.Too bright. Clinically poor: Unacceptable. Replacement necessary. | [Time Frame: Day 0, Month 6, Month 12, Month 18, Month24] | 
| Biological (Number of Restorations with 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. | [Time Frame: Day 0, Month 6, Month 12, Month 18, Month24] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMSO