Post-operative Sensitivity of a Self-adhesive Restorative Material
- Conditions
- Dental Restorations, Permanent
- Interventions
- Procedure: Surefil one™ Self-Adhesive Composite HybridProcedure: Bulk-fill resin composite, (3M, ESPE)
- Registration Number
- NCT05567263
- Lead Sponsor
- King Abdullah University Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surefill One Surefil one™ Self-Adhesive Composite Hybrid Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona), Bulk- Fill Bulk-fill resin composite, (3M, ESPE) 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).
- Primary Outcome Measures
Name Time Method The post-operative sensitivity. One month after the treatment. 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.
- Secondary Outcome Measures
Name Time Method Clinical performance of the restorations 6 months and 1 year after the treatment. 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.
Trial Locations
- Locations (1)
Jordan University of Science and technology
🇯🇴Irbid, Jordan