Regenerative endodontic treatment using demineralized dentin matrix versus RetroMTA for immature permanent single-rooted teeth.

Evaluation of Regenerative Endodontic Treatment for Immature Teeth Using Two Different Forms of Demineralized Dentin Matrix and RetroMTA: Randomized Controlled Clinical Trial

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 9 Years to 15 Years
• Sex: All
• Sponsor: Kafrelsheikh University (Academic / other)
• Locations: 1 site (Kafr ash Shaykh, Kafr Elsheikh)
• Trial ID: NCT07210359 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Kafr ash Shaykh, Kafr Elsheikh

• KafrelsheikhU — Kafr ash Shaykh, Kafr Elsheikh, Egypt (Recruiting)

Study contacts

• Principal investigator: Hisham Abada, Doctors — Academic
• Study coordinator: Dina Sarhan, Masters

Conditions Pulpal Necrosis