Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

Study Overview
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Brief Summary
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The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

Detailed Description
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• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments. Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier. At the end of treatment, the access cavity will be sealed with composite restoration.

Official Title
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Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial

Conditions
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Necrotic Pulp, Apical Periodontitis

Intervention / Treatment
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* Other: Biodentine
* Other: White MTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex). Negative response of pulp tissue to electrical or thermal pulp tester. Widening in lamina dura or periapical radiolucency not more than 3 mm. Exclusion Criteria: 1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm. 3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove). 4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodentine<br>Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment. | Other: Biodentine<br>* Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.<br>|
| Active Comparator: White MTA<br>Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment. | Other: White MTA<br>* MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.<br>* Other names: white mineral trioxide aggregate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discoloration of teeth | Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade. | Up to one Year after completion of regenerative endodontic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of Periapical Tissue | Healing of periapical tissue will be assessed clinically and radiographically through follow up period: 3, 6, 9, 12 months. When the case is clinically asymptomatic: (without sinus tract, swelling, with no palpation, or percussions pain) and radiographically showed absence or reduction of the radiolucency are together will considered successful of regenerative treatment. | after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment | 
| Restoring the sensibility of tooth | Electric pulp tester (EPT) | after 6,9 and Up to 12 months after completion of regenerative endodontic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotic pulp,, Apical periodontitis, Regeneration, MTA, Biodentine