Clinical Performance of Four Restorative Materials in Primary Molars

ConditionsDental Caries Primary Molars

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age4-8

SponsorAl-Azhar University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 4-8 years old.

Primary molars indicated for restorative treatment.

No pulp involvement or history of dental pain.

Cooperative children (Frankl: +ve or ++ve).

Disqualifiers

Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.

Severe developmental enamel defects or insufficient enamel for bonding.

Trial design

Design model

Parallel

Treatments tested in this trial

Cention N
Device
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Stela, SDI, Australia
Device
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
Device
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
Device
Resin-modified glass ionomer cement (Riva Light Cure) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Treatment groups

92 Participants

are divided into 4 treatment groups

Group A: Group A: Cention NExperimental treatment 1 intervention

Group B: Group B: Stela (Self-cure Bulk-fill Composite)Experimental treatment 1 intervention

Group C: Group C: Beautifil II (Nanohybrid Composite)Active comparator 1 intervention

Group D: Group D: Riva Light Cure (RMGIC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

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