Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations

Study Overview
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Brief Summary
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This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial.

Official Title
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A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.

Conditions
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Root Perforation at the Bifurcation Area

Intervention / Treatment
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* Drug: Biodentine
* Drug: MTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vital molars (upper or lower ) suffered from perforation in the bifurcation area of the roots through a process of open access cavity, taking into account the location and size of perforation Perforation should not exceed the size of 3 mm Perforation and must also take into account the time of perforation. Exclusion Criteria: If the molar not vital. If the perforation not in bifurcation root or extended inside the canals. Size of perforation larger than 3 mm. A long time ago on the occurrence of perforation with resorption in tooth structure.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodentine<br>The perforation area of the root is going to be covered by Biodentine | Drug: Biodentine<br>* Biodentine is going to be used as the sealing agent for the perforation.<br>|
| Active Comparator: MTA<br>The perforation area of the root is going to be covered by MTA. | Drug: MTA<br>* MTA is going to be used as the sealing agent for the perforation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success at 3 months following root sealing | Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%. | The success of treatment is assessed at three months following the application of the material | 
| Success at 6 months following root sealing | Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%. | The success of treatment is assessed at 6 months following the application of the material | 
| Success at 9 months following root sealing | Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%. | The success of treatment is assessed at 9 months following the application of the material | 
| Success at 12 months following root sealing | Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%. | The success of treatment is assessed at 12 months following the application of the material | 
| Success at 18 months following root sealing | Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%. | The success of treatment is assessed at 18 months following the application of the material | 
| Success at 24 months following root sealing | Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%. | The success of treatment is assessed at 24 months following the application of the material |