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

Kafrelsheikh University1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2025年9月15日最近更新: 2025年10月7日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Kafrelsheikh University
入组人数: 36
试验地点: 1
主要终点: Maturation of root

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 9 Years 至 15 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.