Regenerative endodontic treatment using demineralized dentin matrix versus RetroMTA for immature permanent single-rooted teeth.
Official title: Evaluation of Regenerative Endodontic Treatment for Immature Teeth Using Two Different Forms of Demineralized Dentin Matrix and RetroMTA: Randomized Controlled Clinical Trial
Run by Kafrelsheikh University · NCT07210359 · Data updated 2026-11-12
This trial will test whether two types of demineralized dentin matrix used as coronal barriers help immature permanent single-rooted teeth (ages 9–15) heal and continue root development better than RetroMTA.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 9 Years to 15 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr ash Shaykh, Kafr Elsheikh) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 20, 2026 |
| Study ends | December 2026 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07210359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are systemically healthy 9–15-year-olds with immature permanent single-rooted teeth diagnosed with irreversible pulpitis or pulpal necrosis who can attend scheduled follow-ups.
✕Probably not a fit
Patients with grossly decayed or fractured teeth needing post-and-core, large periapical lesions (>10 mm), significant root resorption, very narrow apical foramina (<1 mm), or major systemic illness are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized split-mouth clinical trial will enroll 36 healthy patients aged 9–15 with immature single-rooted teeth diagnosed with irreversible pulpitis or pulpal necrosis. Participants are randomly assigned to three groups receiving revascularization with a blood clot scaffold and either RetroMTA, a DDM–TheraCal LC mixture, or TDM–Hydrogel as the coronal barrier. CBCT scans at baseline and at 3, 6, 9, and 12 months will be used to measure outcomes including root length, dentinal wall thickness, apex closure, dentin bridge formation, and lesion size. The trial is conducted at the Endodontic Department, Faculty of Dentistry, Kafrelsheikh University, under institutional ethical approval.
Why it matters
Potential benefit: If successful, DDM-based materials could provide a bioactive coronal barrier that improves root maturation and long-term tooth survival in immature teeth.
How similar studies have gone: Revascularization techniques using blood clot scaffolds and MTA-like materials have shown clinical success in promoting root development, while clinical evidence for demineralized dentin matrix as a coronal barrier remains limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy patients (i.e., free of any systemic diseases). * Patients presenting with immature permanent single-rooted teeth. * Age: 9 -15 years. * Teeth diagnosed as either vital (asymptomatic irreversible pulpitis or symptomatic irreversible pulpitis and the bleeding didn't stop after 5 minutes application of hemostatic agent) or non-vital pulp. Exclusion Criteria: * Patients who are allergic to any drugs used in this study or with systemic illness * Teeth that are grossly decayed or fractured and require post and core as final restorations * Presence of periodontal pockets greater than 4 mm. * Radiographical evidence of apical foramen less than 1 mm. * Presence of periapical radiolucency exceeding 10 mm. * Presence of external or internal root resorption. * Patients with a history of major surgeries like cardiac, kidney transplantation, haemodialysis.
Where it's running
-
KafrelsheikhU
Kafr ash Shaykh, Kafr Elsheikh, Egypt Recruiting
Study contacts
- Principal investigator: Hisham Abada, Doctors — Academic
- Study coordinator: Dina Sarhan, Masters
- Email: dr.dinaabdullah954@gmail.com
- Phone: 01226083903
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.