Not Yet RecruitingNot Applicable

Clinical Performance of Four Restorative Materials in Primary Molars

92 participantsStarted 2026-04-01

Plain-language 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

Who can participate

Age range

4 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Restoration success based on FDI criteria (clinical and radiographic evaluation)

Timeframe: 6 months

Restoration success based on FDI criteria (clinical and radiographic evaluation)

Timeframe: 6 months

Trial details

NCT IDNCT07504393

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Hosam Hassan Metwalli

+201147957878 dr.hosamhassan2@gmail.com

View on ClinicalTrials.gov More Dental Caries trials