Evaluation of Regenerative Endodontic Treatment for Immature Teeth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: human treated dentin matrix hydrogel, Theracal LC - Demineralized dentin matrix combination, Retro Mta.
- Who it may be relevant to
- Registry conditions: Pulpal Necrosis. Basic parameters: 9 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Regenerative Endodontic Treatment for Immature Teeth Using Two Different Forms of Demineralized Dentin Matrix and RetroMTA: Randomized Controlled Clinical Trial
Overview
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
- Procedure human treated dentin matrix hydrogel
material used for regenerative dentistry - Procedure Theracal LC - Demineralized dentin matrix combination
material used for regenerative dentistry - Procedure Retro Mta
material used for regenerative dentistry
Primary outcome measures
- Maturation of root [Time frame: year]
Secondary outcome measures (1)
- resolve of apical lesion if present [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- KafrelsheikhU — Kafr ash Shaykh
Identifiers
NCT: NCT07210359 · 663