Evaluation of Regenerative Endodontic Treatment for Immature Teeth

NCT07210359 · tracked via the Priya Life Science Egypt tracker

Sponsor

Kafrelsheikh University

Phase

Not applicable

Started

2025-09-15

Last updated

2025-10-07

Condition(s) studied

Pulpal Necrosis

Investigational drug(s) / intervention(s)

human treated dentin matrix hydrogelTheracal LC - Demineralized dentin matrix combinationRetro Mta

human treated dentin matrix hydrogel: material used for regenerative dentistry

Theracal LC - Demineralized dentin matrix combination: material used for regenerative dentistry

Retro Mta: material used for regenerative dentistry

Study summary

The goal of this clinical trial is to evaluate if regenerative endodontic treatment using two different forms of demineralized dentin matrix (DDM) can effectively treat immature permanent single-rooted teeth compared to treatment using RetroMTA in patients aged 9 to 15 years. The main questions it aims to answer are:

Does the use of DDM improve clinical and radiographic outcomes such as root length, dentinal wall thickness, and apex closure?

Is DDM a viable bioactive alternative to RetroMTA as a coronal sealing material in regenerative endodontic procedures?

Researchers will compare three groups: one using RetroMTA, one using a DDM-TheraCal LC mixture, and one using TDM-Hydrogel, to see if these materials differ in their effects on regenerative outcomes.

Participants will:

Undergo two treatment visits including canal disinfection, induction of bleeding to form a blood clot scaffold,

Receive placement of one of the study materials over the blood clot as a coronal barrier,

Have clinical examinations and CBCT imaging at baseline and multiple follow-ups up to 12 months to assess treatment success through signs, symptoms, and radiographic changes.

Eligibility

Sex

ALL

Min age

9 Years

Max age

15 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Maturation of root — year
root length increase, root width increase, apical formane closes and dentinal bridge formation over regenerated pulp

Trial sites (1)

Facility	City	Region	Status
KafrelsheikhU	Kafr ash Shaykh	Kafr Elsheikh	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07210359 on ClinicalTrials.gov ↗ ← All trials in Egypt