Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth (RCT)

Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth: A 2-year Randomized Controlled Clinical Trial

The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.

Study Overview

• Status: Recruiting
• Conditions: Proximal Cavities of Posterior Teeth
• Intervention / Treatment: Drug: Beautifil II, Shofu, Japan; Drug: Stela, SDI, Australia

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • El Sherouk City
    • Cairo, El Sherouk City, Egypt, 11837
      • Recruiting
      • Faculty of Dentistry, The British University in Egypt
      • Contact: Dalia Ghalwash Profressor Dr.; Phone Number: +20 19283; Email: Dalia.Ghalwash@bue.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects between the ages of 18-47 years old
2. Primary caries removal
3. Good or moderate oral hygiene
4. Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility)
5. Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance

Exclusion Criteria:

1. Composite or amalgam removal
2. Caries extended to the cemento-enamel junction in Class II caries
3. Grade II or III mobility
4. Considerable periodontal disease without treatment
5. Endodontically treated teeth with extensive loss of tooth tissues
6. Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism.
7. Subjects who are pregnant during the duration of the study
8. Subjects with high caries activity

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beautifil II , Shofu (Light-cured Resin Composite); It is a light-cured bioactive nanohybrid resin composite restorative material	Drug: Beautifil II, Shofu, Japan; Beautifil II is a light-cured bioactive nanohybrid resin composite restorative material. It is a renowned Giomer (Glass-ionomer/composite hybrid) restorative material from Shofu. It is famous for its "S-PRG" (Surface Pre-Reacted Glass) technology, which allows it to release and recharge fluoride like a glass ionomer while maintaining the aesthetics and durability of a composite.
Experimental: Stela, SDI, Australia (Self-cured Resin Composite); It is a novel self-cured bulk-fill restorative material. It is offered in two application forms (Stela Automix & Stela Capsule) that is used in combination with a proprietary adhesive primer (Stela Primer), which does not require light curing, but it undergoes polymerization upon contact with the restorative material in addition to its ability to generate minimal shrinkage stresses. The polymerization starting at the bottom of the cavity helps drastically reduce polymerization shrinkage stress, which is a common cause of post-operative sensitivity.	Drug: Stela, SDI, Australia; Stela, (SDI ) is a novel self-cured bulkfill dental restorative material that is used in combination with an adhesive primer (Stela primer) which doesn't require light curing but it undergoes polymerization upon contact with the restorative material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal contact tightness of examined class II restorations	This primary outcome will be measured using the FDI criteria for direct and indirect restorations	Baseline (after 1 week) and at 6, 12, 18, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Hypersensitivity	One-week post-operative hypersensitivity will be examined using a visual analogue scale following the FDI criteria (absence/presence of hypersensitivity).	Immediate post procedure and after 1 week

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): February 18, 2028
• Study Completion (Estimated): March 18, 2028

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: clinical performance; bioactive; self-cured resin composite; proximal cavities
• Other Study ID Numbers: 25-069; Self-funded (Other Identifier: The British University in Egypt)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No