Evaluation of Regenerative Endodontic Treatment for Immature Teeth

NCT07210359 | Recruiting DMC

• 1 other identifier: 663
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpal Necrosis

Outcome Measures

Primary Outcomes (1)

• Maturation of root

  root length increase, root width increase, apical formane closes and dentinal bridge formation over regenerated pulp

  year

Secondary Outcomes (1)

• resolve of apical lesion if present

  1 year

Other Outcomes (1)

• regain sensibility of pulp

  1 t 2 years

Study Arms (3)

treated hyman dentin matrix hydrogel

ACTIVE COMPARATOR

material used for regenerative dentistry

Procedure: Theracal LC - Demineralized dentin matrix combination; Procedure: Retro Mta

Theracal LC- Demineralized dentina matrix combination

ACTIVE COMPARATOR

material used for regenerative dentistry

Procedure: human treated dentin matrix hydrogel; Procedure: Retro Mta

RetroMTA

ACTIVE COMPARATOR

material used for regenerative dentistry

Procedure: human treated dentin matrix hydrogel; Procedure: Theracal LC - Demineralized dentin matrix combination

Interventions

human treated dentin matrix hydrogel PROCEDURE

material used for regenerative dentistry

Also known as: demineralized dentin matrix

RetroMTA; Theracal LC- Demineralized dentina matrix combination

Theracal LC - Demineralized dentin matrix combination PROCEDURE

material used for regenerative dentistry

RetroMTA; treated hyman dentin matrix hydrogel

Retro Mta PROCEDURE

material used for regenerative dentistry

Theracal LC- Demineralized dentina matrix combination; treated hyman dentin matrix hydrogel

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

KafrelsheikhU

Kafr ash Shaykh, Kafr Elsheikh, 33511, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Demineralized Dentin Matrix

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hisham Abada, Doctors

  Academic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina Sarhan, Masters

CONTACT

01226083903; dr.dinaabdullah954@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at Endodontic department

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

EG (1)