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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bulk- Fill | Active Comparator | 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). |
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| Surefill One | Experimental | Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona), |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulk-fill resin composite, (3M, ESPE) | Procedure | Teeth will be restored with Bulk-fill resin composite, (3M, ESPE) |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghada A Maghaireh | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and technology | Irbid | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37562757 | Derived | Maghaireh GA, Albashaireh ZS, Allouz HA. Postoperative sensitivity in posterior restorations restored with self-adhesive and conventional bulk-fill resin composites: A randomized clinical split-mouth trial. J Dent. 2023 Oct;137:104655. doi: 10.1016/j.jdent.2023.104655. Epub 2023 Aug 9. |
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The design of study will be a split-mouth randomized clinical trial with two study groups.
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All participants will be informed about the nature and objectives of the study; however, they will not be informed what material they would receive.
| Surefil one™ Self-Adhesive Composite Hybrid | Procedure | teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid |
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