Clinical Performance of Alkasite-based Restorations in Children (NCT07263555) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance of Alkasite-based Restorations in Children
Egypt50 participantsStarted 2026-02-01
Plain-language summary
The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.
Who can participate
Age range
4 Years – 6 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:
* • Children aged 4-6 years of both sexes.
* Cooperative children.
* Apparently medically fit children according to parental history.
* Children whose parents agree to sign the informed consent.
* Children whose parents will be able to attend the follow-up.
Teeth:
* Primary molars with occlusal carious lesions (Class I), indicated for direct restorations.
* Teeth without signs of pulpal involvement, abscess, or fractures.
Exclusion Criteria:
Children:
* Children with systemic or mental disorders.
* Children whose parents refused to sign the informed consent.
* Noncompliant parent.
* Uncooperative children.
Teeth:
* Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility).
* Teeth with periapical pathology, internal or external root resorption, or mobility.
* Non-restorable teeth or lacking sufficient structure for restoration
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
1
Incidence of secondary caries
Timeframe: 12 months
Trial details
NCT IDNCT07263555
SponsorCairo University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-02
Contact for this trial
Yusra Hashim Khogali, Bachelor's degree in dentistry