Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Anterior Teeth

Study Overview
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Brief Summary
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the object of this study is to evaluate clinically and radiographically the effect of using Biodentine and Mineral Trioxide Aggregate as coronal plug materials in revascularization of non-vital immature teeth

Detailed Description
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Traumatic injury to the anterior teeth is commonly found among young children, represent one third in boys and one fourth in girls. Because the root development completed two years after eruption of the tooth into the oral cavity, an incomplete root development is one of the most common complication seen in traumatized teeth. Loss of pulp vitality before dentine deposition is completed, leaves a weak root more susceptible to fracture as a result of the thin dentinal walls. It will also lead to a poor crown/root ratio, with possible periodontal injury as a result of increased mobility. Several techniques have been advocated to manage the open apex of immature teeth, including calcium hydroxide (Ca(OH)2) apexification or apical barrier technique with Mineral Trioxide Aggregate (MTA). Although these techniques were successful in obtaining apical closure and healing of the apical pathosis, they have certain disadvantages, as the root walls of the immature tooth remain thin and short as hard tissue barrier formation only occurs apically, with no further root development. As an replacement to traditional methods, the use of a regenerative endodontic procedure has been recommended as it may strengthen the root walls through the deposition of hard tissue and promote the development of a normal apical morphology. MTA was chosen to be placed over blood clot to provide excellent seal and it was considered the recommended material for regenerative procedures.The application of MTA over a blood clot was technically difficult, and condensation resulted in displacement of the material apically. Another important note was the prolonged setting time of MTA which resulted in postponing placement of composite restoration to next appointments and post-treatment tooth discoloration. Biodentine has the same mechanical properties as human dentine, very low cytotoxicity and overcome clinical drawbacks of white MTA. It had better consistency and allow its condensation without any apical displacement. Biodentine sets within twelve minutes, which allow placement of composite restoration in the same appointment. Biodentine is tooth-colored and doesn't cause the discoloration resulted from the presence of the material at level of the orifice.

Official Title
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Clinical and Radiographic Evaluation of Biodentine and Mineral Trioxide Aggregate in Revascularization of Non Vital Immature Permanent Anterior Teeth (Randomized Clinical Study)

Conditions
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Pulp Necrosis

Intervention / Treatment
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* Drug: Biodentine
* Drug: Mineral Trioxide Aggregate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients free from any systemic diseases that may hinder the normal healing process. Age from 8-15 y Tooth with immature root apex (apical opening greater than 1mm) Traumatically or cariously exposed single rooted teeth Non vital permanent anterior tooth with apical periodontitis/abscess Pulp space not requiring post and core for final restoration. Exclusion Criteria: Patients having allergy to medicaments or antibiotics necessary to complete procedure. Tooth with vital pulp or complete root formation. Teeth with internal or external root resorption. Un-cooperative patient

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 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: Biodentine<br>3-4 mm of Biodentine (Septodont, St. Maur-des-Fosses, France) was applied over the clot carefully in group I by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization. | Drug: Biodentine<br>* a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.<br>* Other names: Dentine substitute material;|
| Active Comparator: Mineral Trioxide Aggregate<br>3-4 mm of white Mineral Trioxide Aggregate (Angelus, Londrina, Brazil) was applied over the clot in group II by using amalgam carrier. material was packed lightly with a moistened cotton pellet and Periapical radiograph was taken to confirm coronal seal in the second visit of dental pulp revascularization. | Drug: Mineral Trioxide Aggregate<br>* a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.<br>* Other names: MTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain on biting | Binary outcome (Present or absent). Assessed by asking the patient | 3 months | 
| pain on biting | Binary outcome (Present or absent). Assessed by asking the patient | 6 months | 
| pain on biting | Binary outcome (Present or absent). Assessed by asking the patient | 9 months | 
| pain on biting | Binary outcome (Present or absent). Assessed by asking the patient | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain on percussion | Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror | 3, 6, 9, 12 month | 
| swelling | Binary outcome (Present or absent). Assessed by visual examination of labial vestibule | 3, 6, 9, 12 month | 
| mobility | Binary outcome (Present or absent). Assessed by applying pressure with the ends of 2 metal instruments | 3, 6, 9, 12 month | 
| Sinus or fistula | Binary outcome (Present or absent). Assessed by visual examination of labial vestibule | 3, 6, 9, 12 month | 
| crown discoloration | Binary outcome (Present or absent). Assessed by visual examination of the crown | 3, 6, 9, 12 month | 
| root lengthening | Evaluated radiographically using DIGORA software.Unit of measurements were mm | 3, 6, 9, 12 month | 
| root lengthening | Evaluated radiographically using DIGORA software.Unit of measurements were percent | 3, 6, 9, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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revascularization, necrotic, immature, coronal plug