Clinical Performance of Four Restorative Materials in Primary Molars

March 27, 2026 updated by: Hosam Hassan, Al-Azhar University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Cention N
Device: Cention N
Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.
Other Names:
  • Ivoclar Vivadent
Experimental: Group B: Stela (Self-cure Bulk-fill Composite)
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.
Active Comparator: Group C: Beautifil II (Nanohybrid Composite)
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.
Active Comparator: Group D: Riva Light Cure (RMGIC)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Time Frame: 6 months
6 months
Restoration success based on FDI criteria (clinical and radiographic evaluation)
Time Frame: 6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAU-PEDO-1394-5575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the informed consent provided by the participants and the ethical approval granted for this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on Cention N

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe