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Clinical Performance of Four Restorative Materials in Primary Molars

NCT07504393 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-10-31
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07504393 on ClinicalTrials.gov