Clinical Performance of Four Restorative Materials in Primary Molars

Al-Azhar University

Status: Not yet enrolling

Conditions: Dental Caries; Primary Molars

Treatments: Device: Stela, SDI, Australia; Device: Cention N; Device: Resin modified glass ionomer cement; Device: Beautifil II, Shofu, Japan

Study type: Interventional

Funder types: Other

Identifiers

NCT07504393

AAU-PEDO-1394-5575

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 4-8 years old.
2. Primary molars indicated for restorative treatment.
3. No pulp involvement or history of dental pain.
4. Cooperative children (Frankl: +ve or ++ve).

Exclusion criteria

1. Pulp exposure after caries removal or clinical signs of irreversible pulpitis/necrosis.
2. Severe developmental enamel defects or insufficient enamel for bonding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 4 patient groups

Group A: Cention N

Experimental group

Treatment:

Device: Cention N

Group B: Stela (Self-cure Bulk-fill Composite)

Experimental group

Treatment:

Device: Stela, SDI, Australia

Group C: Beautifil II (Nanohybrid Composite)

Active Comparator group

Treatment:

Device: Beautifil II, Shofu, Japan

Group D: Riva Light Cure (RMGIC)

Active Comparator group

Treatment:

Device: Resin modified glass ionomer cement