The Effect of MTA and PRF Application in Periapical Lesions

Study Overview
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Brief Summary
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A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly selected from December 2016-November 2017. Patients were informed about the surgical procedure and signed a consent form. Groups were divided in to 4; as control, MTA (mineral trioxide aggregate), PRF (platelet rich fibrin) and MTA+PRF groups. Apical resection was performed in all groups. No other interventions were made to the control group. Routine radiographs were taken in the 1st. 3th and 6th months. In the (approximately) 12th month of the procedures computerized tomography scans were taken. Primary healing of the periapical tissues were evaluated and the outcomes were measured. Patients have still been under control for the long term outcomes of the study.

Detailed Description
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44 apically infected periapical lesions were decided to enroll to the study from December 2016-November 2017. However; a total of 40 periapical lesions undergoing apical surgery were recruited for the planned clinical trial in the end. The study was conducted under randomized controlled protocol. Patients were informed about the surgical procedures and signed a consent form. The anticipated outcomes, possible risks and benefits of the study as well as the alternative treatment options were explained to the patients. Groups were designed to have 10 patients in each and randomly divided into four as; control, MTA, PRF and MTA+PRF. Apical resection was performed in all groups. No other interventions were made to the control group. Routine radiographs were taken in the 1st. 3th and 6th months. In the 12th month of the procedures computerized tomography (CT) scans were taken. Primary healing of the periapical tissues were evaluated according to the volumes and the densities of the lesions. Outcomes were measured. Comparison between the initial and the last 3D CT scan volumes were made by medical image processing software (MIMICS, Belgium). Patients have still been under control for the long term outcomes of the study.

Official Title
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Assessment of Bone Healing After MTA and PRF Application in Periapical Lesions By Using CBCT

Conditions
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Apical Periodontitis, Wound Heal

Intervention / Treatment
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* Procedure: control group
* Procedure: MTA group
* Procedure: PRF group
* Procedure: MTA + PRF group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single rooted canals Failed previous root canal treatment Retreatment at least 1 year previously Previous surgery with unresolved bony lesion Exclusion Criteria: More than single rooted canals Chronic generalized periodontitis Any systemic disease contraindicating oral surgical procedures Evidence of root fracture Resorptive processes involving more than apical third of the root

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Sham Comparator: control group<br>Apical resection group. Only root resection was applied without any other interventions (like prf or mta) | Procedure: control group<br>* a procedure used to prevent or resolves apical periodontitis.<br>* Other names: root resection;|
| Experimental: MTA group<br>Root resection was applied and MTA was inserted through the apical foramen | Procedure: MTA group<br>* a procedure used to prevent or resolves apical periodontitis.<br>* Other names: mineral trioxide aggregate;|
| Experimental: PRF group<br>Root resection was applied and PRF was placed to the surgically prepared area | Procedure: PRF group<br>* a procedure that is used for wound healing<br>* Other names: platelet rich fibrin;|
| Experimental: MTA + PRF group<br>Root resection was applied. MTA was inserted through the apical foramen and PRF was placed to the surgically prepared area | Procedure: MTA + PRF group<br>* a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.<br>* Other names: mineral trioxide aggregate + mineral trioxide aggregate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic success - in volume | Evaluation of tomographic outcomes (differences between preoperative and postoperative volume of periapical lesions) | 1 year | 
| Radiographic success - in density | Evaluation of tomographic outcomes (differences between preoperative and postoperative density of periapical lesions) | 1 year |