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

NCT07457749 | Recruiting Early Phase 1 DMC

• 2 other identifiers: 25-069Self-funded
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proximal Cavities of Posterior Teeth

Keywords

clinical performance; self-cured resin composite; bioactive; proximal cavities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Hypersensitivity

  Immediate post procedure and after 1 week

Study Arms (2)

Beautifil II , Shofu (Light-cured Resin Composite)

ACTIVE COMPARATOR

It is a light-cured bioactive nanohybrid resin composite restorative material

Drug: Beautifil II, Shofu, Japan

Stela, SDI, Australia (Self-cured Resin Composite)

EXPERIMENTAL

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

Interventions

Stela, SDI, Australia DRUG

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.

Stela, SDI, Australia (Self-cured Resin Composite)

Beautifil II, Shofu, Japan DRUG

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.

Beautifil II , Shofu (Light-cured Resin Composite)

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

Faculty of Dentistry, The British University in Egypt

Cairo, El Sherouk City, 11837, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at the Conservative Department, Faculty of Dentistry, The British University in Egypt

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): February 18, 2028
• Study Completion (Estimated): March 18, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)