RecruitingNot ApplicableNCT07210359

Evaluation of Regenerative Endodontic Treatment for Immature Teeth

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


Sponsor

Kafrelsheikh University

Enrollment

36 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

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

Min Age: 9 YearsMax Age: 15 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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.

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Interventions

PROCEDUREhuman treated dentin matrix hydrogel

material used for regenerative dentistry

PROCEDURETheracal LC - Demineralized dentin matrix combination

material used for regenerative dentistry

PROCEDURERetro Mta

material used for regenerative dentistry


Locations(1)

KafrelsheikhU

Kafr ash Shaykh, Kafr Elsheikh, Egypt

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NCT07210359