NCT05567263|Completed
Post-operative Sensitivity of a Self-adhesive Restorative Material
Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
Loading search results
Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
Sponsor study identifier
interventional
88
1 country
1
Study Start
January 1, 2022
Actual (reported)Primary Completion
March 30, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2022
Actual (reported)October 3, 2022
Actual (reported)October 5, 2022
Actual (reported)March 30, 2024
Actual (reported)June 30, 2024
Actual (reported)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.
Clinical performance of the restorations
6 months and 1 year after the treatment.
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).
Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona),
Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)
teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Jordan University of Science and technology
Irbid, Jordan
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.
Ghada A Maghaireh
Jordan University of Science and Technology
88 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2022
First Posted
October 5, 2022
Contact the study team to confirm eligibility.
Study Start
January 1, 2022
Actual (reported)Primary Completion
March 30, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)Last Updated
July 12, 2024
Record last verified: 2024-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: