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Clinical Trials/NCT05567263
NCT05567263
Completed
Not Applicable

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

King Abdullah University Hospital1 site in 1 country88 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Restorations, Permanent
Sponsor
King Abdullah University Hospital
Enrollment
88
Locations
1
Primary Endpoint
The post-operative sensitivity.
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ghada Maghaireh

Principal Investigator

King Abdullah University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

The post-operative sensitivity.

Time Frame: 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 Outcomes

  • Clinical performance of the restorations(6 months and 1 year after the treatment.)

Study Sites (1)

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