Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth

Study Overview
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Brief Summary
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the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth

Detailed Description
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The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem. In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture. Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue. MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties. Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA

Official Title
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Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: A Randomized Clinical Trial

Conditions
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Pulp Necrosis

Intervention / Treatment
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* Other: Revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of patient range from 8-14 y. Patients are free from any systemic diseases that may hinder the normal healing process. Non vital permanent anterior teeth with open apex. Pulp space not needed for post and core for final restoration. Compliant patient/parent. Exclusion Criteria: Patients having allergy to medicaments and antibiotics necessary to complete the procedure. Tooth with vital pulp or complete root formation. Teeth with internal or external root resorption. Un-cooperative patients

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Enosequence<br>3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization | Other: Revascularization<br>* a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis<br>* Other names: pulp regeneration;|
| Active Comparator: Mineral Trioxide Aggregate<br>3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization | Other: Revascularization<br>* a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis<br>* Other names: pulp regeneration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discoloration | Asking patient question (Binary:present or absent) | 1 month | 
| discoloration | Asking patient question (Binary:present or absent) | 3 months | 
| dicoloration | Asking patient question (Binary:present or absent) | 6 months | 
| discoloration | Asking patient question (Binary:present or absent) | 9 months | 
| discoloration | Asking patient question (Binary:present or absent) | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain | asking the patient (Binary: present or Absent) | 1,3, 6, 9 and 12 months | 
| color stability | Operator and supervisor evaluation (Using shade guide) | 1,3, 6, 9 and 12 months | 
| Pain on percussion | Assessed by back of the mirror (Binary: present or absent) | 1,3, 6, 9 and 12 months | 
| Swelling | assessed by visual examination (Binary:present or absent) | 1,3, 6, 9 and 12 months | 
| Sinus or fistula | assessed by visual examination (Binary:present or absent) | 1,3, 6, 9 and 12 months | 
| Root lengthening | assessed radiographically (DIGORA® for Windows software) | 6 and 12 months |