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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07210359
Enrollment
36
Registered
2025-10-07
Start date
2025-09-15
Completion date
2026-12-31
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpal Necrosis

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.

Detailed description

The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Kafrelsheikh University, and carried out at Endodontic Department, Faculty of Dentistry, Kafrelsheikh University. 36 patients of both sexes aged from 9 to 15 years old were selected with an immature teeth with 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 are indicated for regenerative endodontic procedure. Patients will be divided randomly into three equal groups (n = 12): Group 1(control group): Revascularization will be done using blood clot and RetroMTA as coronal barrier. Group 2: Revascularization will be done using blood clot and DDM-TheraCal LC mixture paste as coronal barrier. Group 3: Revascularization will be done using blood clot and TDM-Hydrogel as coronal barrier. CBCT image will be obtained for baseline records before treatment and after placement of the final resin restoration, then the patients will be recalled after 3, 6, 9 and 12 months for evaluating any changes in dentin bridge formation, root length, root canal width, apex diameter and lesion size if present.

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

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Maturation of rootyearroot length increase, root width increase, apical formane closes and dentinal bridge formation over regenerated pulp

Secondary

MeasureTime frameDescription
resolve of apical lesion if present1 yearif there is any apical lesion, it will resolve and new bone formation takes place.

Other

MeasureTime frameDescription
regain sensibility of pulp1 t 2 yearsnerve supply of pulp is regenerated with time but not primary outcome

Countries

Egypt

Contacts

Primary ContactDina Sarhan, Masters
dr.dinaabdullah954@gmail.com01226083903

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026