Endodontic Microsurgery With the Use of L-PRF Block

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

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.

Study Overview

• Status: Recruiting
• Conditions: Apical Periodontitis; Apical Periodontal Cyst
• Intervention / Treatment: Procedure: Endodontic Microsurgery

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nastaran Meschi, PhD; Phone Number: +32 0032476313889; Email: Nastaran.meschi@kuleuven.be
• Study Contact Backup: Name: Joëy d'Hoop, DDS; Phone Number: 0032477362532; Email: Joey.dhoop@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With L-PRF Block	Procedure: Endodontic Microsurgery; 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.
Active Comparator: No L-PRF Block	Procedure: Endodontic Microsurgery; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Nastaran Meschi, DDS, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Periodontitis; Periapical Periodontitis; Radicular Cyst; Periodontal Cyst
• Other Study ID Numbers: S63971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No