CompletedNot Applicable

Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars

Egypt74 participantsStarted 2024-08-20

Plain-language summary

The goal of this randomized controlled clinical trial is to to evaluate the clinical performance and radiographic success of BioFlex crowns versus SSCs using Hall Technique in primary dentition. The main questions it aims to answer are: Does bioflex crowns have the same clinical performance and radiographic success of stainless steel crowns when placed using Hall Technique? will bioflex crowns alter the occlusal vertical dimensions or affect the tempomandibular joint? If there is a comparison group: Researchers will compare bioflex crown to stainless steel crown to see of the bioflex crowns are effective as stainless steel crowns when placed using hall technique Participants will recieve bioflex crown and stainless steel crown according to randomization and they will be followed up immediately after treatment, after 2 weeks , after 1 months , after 3 months , after 6 months and after 12 months

Who can participate

Age range

4 Years – 7 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: \- Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (ICDAS codes: 3-5). Exclusion Criteria: Teeth will be excluded if they exhibit: * Clinical or radiographic signs of irreversible pulpitis. * Presence of fistula or abscess. * Spontaneous pain. * Pulp exposure. * Bruxism. * Pathologic mobility (identified by gently rocking the tooth buccolingually using tweezers).

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

To evaluate the clinical performance of BioFlex crowns versus SSCs using HT.

Timeframe: 12 months

To evaluate the radiographic success of BioFlex crowns versus SSCs using HT.

Timeframe: 12 months

Trial details

NCT IDNCT06847646

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-20

View on ClinicalTrials.gov More BioFlex Crowns Using Hall Technique trials