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Evaluation of Regenerative Endodontic Treatment for Immature Teeth

ConditionPulpal Necrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-15
SponsorKafrelsheikh University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • human treated dentin matrix hydrogel

    Procedure/Surgery

    material used for regenerative dentistry

  • Theracal LC - Demineralized dentin matrix combination

    Procedure/Surgery

    material used for regenerative dentistry

  • Retro Mta

    Procedure/Surgery

    material used for regenerative dentistry

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: treated hyman dentin matrix hydrogelActive comparator 2 interventions
Group B: Theracal LC- Demineralized dentina matrix combinationActive comparator 2 interventions
Group C: RetroMTAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Maturation of root

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

Time frame
year

Secondary outcomes

1

resolve of apical lesion if present

if there is any apical lesion, it will resolve and new bone formation takes place.

Time frame
1 year

Other outcomes

1

regain sensibility of pulp

nerve supply of pulp is regenerated with time but not primary outcome

Time frame
1 t 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov
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