Post-operative Sensitivity of a Self-adhesive Restorative Material

Study Overview
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Brief Summary
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Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations

Official Title
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Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.

Conditions
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Dental Restorations, Permanent

Intervention / Treatment
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* Procedure: Bulk-fill resin composite, (3M, ESPE)
* Procedure: Surefil one™ Self-Adhesive Composite Hybrid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years' old Teeth are vital Teeth are periodontal healthy Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth Patient did not receive orthodontic treatment Good level of oral hygiene. Exclusion Criteria: Non-vital or endodontically treated teeth (Profound, chronic) periodontitis Deep carious defects (close to pulp, < 1mm distance) Heavy occlusal contacts or history of bruxism Poor oral hygiene Sustained dentin hypersensitivity Taking anti-inflammatory, analgesic, or psychotropic drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The design of study will be a split-mouth randomized clinical trial with two study groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bulk- Fill<br>Restorative procedure of the teeth will be performed using Filtek-Bulk Fill Posterior Restorative, Bulk-fill resin composite, (3M, ESPE) following application of an etch-and-rinse single bottle adhesive (3M, ESPE). | Procedure: Bulk-fill resin composite, (3M, ESPE)<br>* Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)<br>|
| Experimental: Surefill One<br>Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona), | Procedure: Surefil one™ Self-Adhesive Composite Hybrid<br>* teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The post-operative sensitivity. | For the evaluation of post-operative sensitivity, participants will be asked to record whether they experienced sensitivity using a 0-4 numerical rating scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe). The patients will be asked to fill in the pain scale forms 24 hours after the restorative procedure and daily up to seven days, and at 2 weeks and 1 month intervals. | One month after the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of the restorations | All restorations will be evaluated at 6 months and 1-year post-restoration using the United States Public Health Service, USPHS criteria using the Alpha, Bravo and Charlie scale to evaluate the following parameters: retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness. | 6 months and 1 year after the treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Composite, self-adhesive, sensetivity