Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Performance of Four Restorative Materials in Primary Molars
Sponsor: Al-Azhar University
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
Official title: 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
Key Details
Gender
All
Age Range
4 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2026-04-01
Completion Date
2026-11
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Cention N
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
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.
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.
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.