Endodontic Microsurgery With the Use of L-PRF Block

Not Applicable

Recruiting

• Conditions: Apical Periodontitis; Apical Periodontal Cyst
• Interventions: Procedure: Endodontic Microsurgery

• Registration Number: NCT05379010
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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 Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With L-PRF Block	Endodontic Microsurgery	-
No L-PRF Block	Endodontic Microsurgery	-

Primary Outcome Measures

Name	Time	Method
Amount of peri-apical bone healing	1 year	Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).

Secondary Outcome Measures

Name	Time	Method
Patient related outcomes	7 days	Discomfort assessed with a Visual Analogue Scale ranging from 1 to 5 each day during the first 7 days post-op.
Bone or scar tissue healing	1 year	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.
Success & survival rate	1 year	Success \& survival rate
Dentinal defects	1 year	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.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium