Endodontic Microsurgery With the Use of L-PRF Block

Study Overview
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Brief Summary
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This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions.

Detailed Description
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This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (control group).

Official Title
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Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial

Conditions
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Apical Periodontitis, Apical Periodontal Cyst

Intervention / Treatment
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* Procedure: Endodontic Microsurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Provision of Informed Consent Patients from 18 years old Patients in need of an EMS EMS is the only option to cure the periapical lesion A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT Exclusion Criteria Unlikely to be able to comply with the study procedures, as judged by the investigator Orthograde endodontic (re)treatment is indicated Known or suspected current malignancy History of chemotherapy within 5 years prior to study History of radiation in the head and neck region History of other metabolic bone diseases History of bleeding disorders HIV disease Hepatitis B or C Systemic disease (osteoporosis, diabetes…)

Ages Eligible for Study
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Minimum Age: 18 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: With L-PRF Block<br> | Procedure: Endodontic Microsurgery<br>* Surgical removal of 3 millimeters of the root-end, removal of the apical pathology, Root-end preparation and retrograde filling. The entire procedure is done under magnification.<br>|
| Active Comparator: No L-PRF Block<br> | Procedure: Endodontic Microsurgery<br>* Surgical removal of 3 millimeters of the root-end, removal of the apical pathology, Root-end preparation and retrograde filling. The entire procedure is done under magnification.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of peri-apical bone healing | Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient related outcomes | Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op. | 7 days | 
| Patient related outcomes | Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op. | 7 days | 
| Patient related outcomes | Discomfort assessed with a Visual Analogue Scale ranging from 1 to 5 each day during the first 7 days post-op. | 7 days | 
| Bone or scar tissue healing | Bone or scar tissue healing: Volumetric analysis using Cone-Beam Computed Tomography. Pre-operative CBCT data will be matched with the post-op CBCT scans in order to assess the volumetric changes during 1 year. | 1 year | 
| Success & survival rate | Success & survival rate | 1 year | 
| Dentinal defects | Dentinal defects: in the apical root before and after resection. Potential cracks and fractures that occur during the follow-up period will be assessed on CBCT en reported. | 1 year |