Not Yet RecruitingNot Applicable

Clinical and Radiographic Evaluation of Injectable Composite Versus Packable Composite in Restoring of Primary Molars

Egypt32 participantsStarted 2026-05-01

Plain-language summary

This randomized clinical trial aims to compare the clinical and radiographic performance of injectable composite versus packable composite in restoring cavitated primary molars in children aged 4 to 8 years. Study Purpose To determine whether injectable composite performs as well as packable composite in Class II restorations in primary molars clinically and radiographically.

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: * Patients: * Children aged 4-8 years. * Medically free. Teeth: * Restorable Class II cavities. * Asymptomatic tooth. Pre-operative radiographic examination: * Absence of periapical or inter-radicular radiolucency. * Absence of widening of periodontal ligaments space. * Absence of internal or external root resorption. Exclusion Criteria: * Patients: * Uncooperative children. * Unable to attend follow-up visits. * Parents refuse to sign the informed consent. * Children participating in any other clinical trial involving fluoride therapy or other interventions that could directly influence caries development during the study period. Teeth: * Teeth which were previously restored. * Mobility. Pre-operative radiographic examination: * Caries extending deep sub-gingivally. * The tooth is about to exfoliate.

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

Clinical Assessment of Injectable Composite Versus Packable Composite in The Restoration of Cavitated Primary Molars

Timeframe: Time: T0 = baseline assessment and procedure will be done. T1 =3 months follow up. T2 = 6 months follow up. T3 = One-year follow-up.

Trial details

NCT IDNCT07239154

SponsorEslam samy abdel monaem kalboush

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Eslam Kalboush, Mcs

01028992916 eslam.samy@dentistry.cu.edu.eg

View on ClinicalTrials.gov More Dental Caries in Children trials