Dental Restorations, Permanent
Conditions
Keywords
Composite, self-adhesive, sensetivity
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
Interventions
PROCEDUREBulk-fill resin composite, (3M, ESPE)
Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)
PROCEDURESurefil one™ Self-Adhesive Composite Hybrid
teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid
Sponsors
Jordan University of Science and Technology
King Abdullah University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
All participants will be informed about the nature and objectives of the study; however, they will not be informed what material they would receive.
Intervention model description
The design of study will be a split-mouth randomized clinical trial with two study groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Jordan
Outcome results
None listed