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NCT Number: NCT07504393

Clinical Performance of Four Restorative Materials in Primary Molars

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

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Key information

Conditions

Dental Caries Primary Molars Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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

Treatment and study plan

Cention N

Device

Alkasite restorative material (Cention N) used for direct restoration of carious primary molars according to the manufacturer's instructions.

Other names: Ivoclar Vivadent

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.

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)

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hosam Hassan Metwalli

CONTACT

[email protected]

+201147957878

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 31, 2026
Registry last updated: Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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