Post-operative Sensitivity of a Self-adhesive Restorative Material

King Abdullah University Hospital

Status: Completed

Conditions: Dental Restorations, Permanent

Treatments: Procedure: Bulk-fill resin composite, (3M, ESPE); Procedure: Surefil one™ Self-Adhesive Composite Hybrid

Study type: Interventional

Funder types: Other

Identifiers

NCT05567263

20210419

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Bulk- Fill

Active Comparator group

Description:

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).

Treatment:

Procedure: Bulk-fill resin composite, (3M, ESPE)

Surefill One

Experimental group

Description:

Restorative procedure of the teeth will be performed using Surefil one™ Self-Adhesive Composite Hybrid (Dentsply, Sirona),

Treatment:

Procedure: Surefil one™ Self-Adhesive Composite Hybrid