Regenerative Endodontics for Non-vital Primary Molars

Study Overview
=================
Brief Summary
-----------------
Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

Detailed Description
-----------------
Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups: Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months

Official Title
-----------------
Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)

Conditions
-----------------
Pulp and Periapical Tissue Disease

Intervention / Treatment
-----------------
* Procedure: Regeneration in primary molars by using MTA
* Procedure: Regeneration in primary molars by using biodentine
* Procedure: Conventional Root canal treatment in primary molars


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-vital mandibular primary second molar. Restorable tooth Exclusion Criteria: Patients allergic to medicaments or antibiotics necessary to complete the procedure. Special Health Care Needs Excessive mobility Presence of internal or external root resorption.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional root canal treatment<br>The caries will be removed. An excavator will be used to remove the coronal portion of the dental pulp while the radicular portion will be cleaned using k- files. 2.5% Sodium hypochlorite will be used as irrigant solution.The canals will be filled with ZOE cement and a stainless-steel crown will be inserted to restore the tooth. | Procedure: Conventional Root canal treatment in primary molars<br>* Removal of pulp tissue from the canals of primary molars<br>|
| Experimental: Regenerative endodontic treatment using MTA<br>Access cavity will be prepared in each primary molar then each canal will be copiously irrigated by sodium hypochlorite. Triple antibiotic paste will be inserted in eash canal then sealed with temporary restoration till the second visit. In the second visit canals will be irrigated with EDTA, after that induction of bleeding will be created by overinstumentation inside each canal. Finally sealed with MTA under the GIC restoration and S.S.C | Procedure: Regeneration in primary molars by using MTA<br>* Regenerative endodontic procedure in nonvital primary molars using MTA capping material<br>|
| Experimental: Regenerative endodontic treatment using Biodentine<br>Access cavity will be prepared in each primary molar then canals will be copiously irrigated by sodium hypochlorite. Mixture of Triple antibiotic paste will be introduced in eash canal then cavity will be sealed with temporary restoration till the second visit. In the second visit canals will be irrigated with EDTA, after that bleeding will be created by overinstumentation inside each canal. Finally sealed with biodentine under the GIC restoration and S.S.C | Procedure: Regeneration in primary molars by using biodentine<br>* Regenerative endodontic treatment in primary molars with biodentine as capping material<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical measures | 42 children with no pain or swelling (i.e) successful outcomes | 12 months | 
| Radiographic measures | 42 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regenerative endodontic treatment