Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Restoring Occlusal Cavities of Posterior Teeth.

March 14, 2026 updated by: ISRAA FOAD, British University In Egypt

Two-Year Clinical Performance of Self-Cured Resin Composite in Comparison to Light-Cured Bioactive Resin Composite in Restoring Occlusal Cavities of Posterior Teeth. (A Randomized Controlled Clinical Trial)

Introduction: Resin composite restorations are among the most commonly used materials for restoring posterior teeth due to their aesthetic and mechanical properties. Self-cured resin composites have emerged as a promising option to overcome some of the limitations of conventional light-cured composites.

Aim: The aim of this study is to evaluate the effect of self-cured resin composite in restoring occlusal cavities of posterior teeth over a period of two years. The results will contribute to clarifying its efficiency and safety as a treatment option in daily clinical practice.

Research Steps: Fifty affected teeth will be selected and randomly allocated into groups.

Group (A): Self-cured resin composite group - self-cured resin composite will be used.

Group (B): Bioactive nano-hybrid resin composite group - bioactive nano-hybrid resin composite will be used.

The restorations will be evaluated after placement.

Introduction:

Resin composite restorations are among the most widely used materials in restorative dentistry due to their favorable aesthetic and physical properties. However, the success of these restorations largely depends on the type of material used and the technique of application. Conventional light-cured composites are the most common option, yet they may present certain limitations in cases where adequate isolation is difficult to achieve or in posterior areas of the mouth.

In contrast, self-cured resin composites have emerged as a promising alternative because of their ability to polymerize chemically without the need for a light source. These materials are characterized by ease of use and the possibility of application under limited clinical conditions, making them suitable in certain clinical situations.

Aim of the Study:

The aim of this randomized controlled clinical trial is to evaluate the clinical performance of a newly introduced self-cured resin composite (Stela, SDI, Australia) in class I occlusal cavities of posterior teeth compared to light-cured Nano-hybrid bioactive resin composite (Beautifill II, Shofu, Japan) regarding functional properties over a follow-up of 2 years.

Research Question:

Does the clinical performance of self-cured resin composite restorations differ from light cured nano-hybrid bioactive resin composite in class I cavities?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elshorouk City
      • Cairo, Elshorouk City, Egypt, 4914085
        • The british university in egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients typically between 18 to 50 years old.
  • Males or Females.
  • Co-operative patients approving the trial.
  • Good oral hygiene.

Exclusion Criteria:

  • Lack of compliance.
  • Patients with bad oral hygiene.
  • Patients who are allergic to any ingredients used in the study.
  • Medically compromised patients with systemic complications that would alter the treatment.
  • Inability to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bioactive Nano-hybrid composite group
Procedure: Bioactive Nano-hybrid composite

After cavity disinfection, Selective etching of enamel will be done using 37% phosphoric acid etch on all enamel margins after protection of dentin for 20 seconds followed by rinsing and dryness. Then, a universal adhesive will be applied using micro brush on all cavity (Enamel and Dentin). A gentle air blast will be done for the adhesive for 5 seconds then cured for 20 seconds according to the manufacturer instructions. A thin layer (1mm) of highly filled flowable composite will be applied on the cavity floor and distributed using the tip of the explorer then cured for 20 seconds according to the manufacturer instructions. Finally, nano hybrid composite will be packed incrementally following the tooth anatomy and each increment will be cured for 20 seconds according to the manufacturer instructions.

For both groups sequential finishing and polishing will be done using red and yellow coded finishing stones, polishing tips and polishing paste according to the manufacturer instructions.
Experimental: Self-cured composite group
Procedure: Self Cured Composite
After cavity disinfection, the adhesive protocol system will be applied on the cavity and margins according to the manufacturer instructions using Stela primer then stela composite will be applied in single increment covering the margins. A period of 4 minutes is required till complete setting before starting finishing and polishing procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional properties as assisted by FDI criteria for direct restorations
Time Frame: 2 years
Unit of measurement is numbers and percentages
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British University In Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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