Post-operative Sensitivity of a Self-adhesive Restorative Material

King Abdullah University Hospital88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Restorations, Permanent

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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.

Time frame: One month after the treatment.

Secondary Outcomes

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.

Time frame: 6 months and 1 year after the treatment.