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

NCT07480070 | Completed

• 1 other identifier: 25-068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Composite Restoration

Keywords

Class I cavities; Clinical Performance; FDI criteria; Self cured resin composite; Occlusal cavities; Two-Year; Light cured resin composite; Bioactive resin composite

Outcome Measures

Primary Outcomes (1)

• Functional properties as assisted by FDI criteria for direct restorations

  Unit of measurement is numbers and percentages

  2 years

Study Arms (2)

Bioactive Nano-hybrid composite group

ACTIVE COMPARATOR

Procedure: Bioactive Nano-hybrid composite

Self-cured composite group

EXPERIMENTAL

Procedure: Self Cured Composite

Interventions

Bioactive Nano-hybrid composite PROCEDURE

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.

Bioactive Nano-hybrid composite group

Self Cured Composite PROCEDURE

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

Self-cured composite group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, Elshorouk City, 4914085, Egypt

Location

MeSH Terms

Interventions

Palfique self-cured composite

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 18, 2026
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

EG (1)