Post-operative Sensitivity of a Self-adhesive Restorative Material

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Dental Restorations, Permanent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The design of study will be a split-mouth randomized clinical trial with two study groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

All participants will be informed about the nature and objectives of the study; however, they will not be informed what material they would receive.

Study Groups

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Bulk- Fill

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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)

Surefill One

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

Group Type EXPERIMENTAL

Surefil one™ Self-Adhesive Composite Hybrid

Intervention Type PROCEDURE

teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid

Interventions

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

Teeth will be restored with Bulk-fill resin composite, (3M, ESPE)

Intervention Type PROCEDURE

Surefil one™ Self-Adhesive Composite Hybrid

teeth will be restored with Surefil one™ Self-Adhesive Composite Hybrid

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes