NCT07457749

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: British University In Egypt · Academic / Other
• Sex: All
• Age: 18 Years – 47 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-02-18
• Primary completion: 2028-02-18
• Completion: 2028-03-18
• First posted: 2026-03-09
• Last updated: 2026-03-19

Locations

1 site across 1 country: Egypt