Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time. Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.

Detailed Description
-----------------
The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth. to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.

Official Title
-----------------
Clinical and Radiographic Evaluation of Neo MTA Versus Conventional White MTA in Revascularization of Non-Vital Immature Permanent Anterior Teeth: A Randomized Controlled Trial

Conditions
-----------------
Nonvital Tooth

Intervention / Treatment
-----------------
* Biological: NeoMTA nusmile
* Biological: White MTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of patients: 7-15years old. Free from any systemic diseases that may affect the normal healing process. Tooth with immature root apex. Traumatically or cariously exposed non vital permanent anterior tooth. 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 procedure. Tooth with vital pulp or complete root formation. Teeth with internal or external root resorption. Un-cooperative patients. Luxative injuries. Teeth with a root fracture Alveolar fracture Subjects with chronic systemic illness. Subjects with poor oral hygiene. Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeoMTA (intervention group)<br>Revascularization with NeoMTA as coronal plug. | Biological: NeoMTA nusmile<br>* A new formulation of MTA was developed in which bismuth oxide was omitted.<br>|
| Active Comparator: White MTA (Control group)<br>Revascularization with Conventional white mineral trioxide aggregate (White MTA) as coronal plug. | Biological: White MTA<br>* Revascularization with Conventional white mineral trioxide aggregate as coronal plug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discoloration/ Staining potential | Using spectrophotometer by operator | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on biting | Verbal questioning of the patient | 9 month | 
| Pain on percussion | Using back of the mirror | 9 month | 
| Sinus or fistula, recurrent swelling | Visual examination by operator | 9 month | 
| Root lengthening | Radiographic Digora image analysis software i.e. Digora for windows software DFW | 9 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulp revascularization, endodontic regeneration, NeoMTA