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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Self-cure bulk-fill resin composite (Stela; SDI) used for direct restoration of carious primary molars according to the manufacturer's instructions.
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 (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Time frame: 6 months
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Clinical and radiographic success of restorations assessed using the Fédération Dentaire Internationale (FDI) World Dental Federation criteria (scores 1-5). Scores 1-3 are considered clinically acceptable; scores 4-5 are considered clinically unacceptable (repair or replacement indicated).
Time frame: 6 months
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