NCT07504393

Clinical Performance of Four Restorative Materials in Primary Molars

Clinical Evaluation of an Alkasite Restoration Material (Cention N) and Self-cure Composite (Stela; SDI) Compared to Conventional Composite and Resin-modified Glass Ionomer in Primary Molars: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aims to compare the clinical and radiographic performance of four direct restorative materials used for restoring carious primary molars in children. Eligible children aged 4-8 years with posterior primary molars requiring direct restoration will be randomly allocated (1:1:1:1) to receive one of the following materials: an alkasite restorative material (Cention N), a self-cure bulk-fill resin composite (Stela; SDI), a conventional light-cured nanohybrid resin composite (Beautifil II), or a resin-modified glass ionomer cement (Riva Light Cure). Restorations will be evaluated using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria. Postoperative sensitivity will be assessed at 48 hours using a 0-10 visual analogue scale (VAS). Clinical and radiographic follow-up assessments will be conducted at baseline and at scheduled recall visits

Conditions

• Dental Caries
• Primary Molars

Interventions

Type	Name	Description
DEVICE	Cention N	Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
DEVICE	Stela, SDI, Australia	Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions.
DEVICE	Beautifil II, Shofu, Japan	Light-cured nanohybrid resin composite (Beautifil II) used for direct restoration of carious primary molars according to the manufacturer's instructions.
DEVICE	Resin modified glass ionomer cement	Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-31
• Completion: 2026-11-01
• First posted: 2026-03-31
• Last updated: 2026-03-31