Endodontic Microsurgery With the Use of L-PRF and an Occlusive Membrane: a Randomized Controlled Clinical Trial

Not Applicable

Completed

• Conditions: Periapical Periodontitis
• Interventions: Procedure: EMS; Device: + occlusive membrane; Device: conebeam CT

• Registration Number: NCT02528240
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

This study evaluates the effect of leucocyte and platelet rich fibrin (L-PRF) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing. Also the influence of an occlusive membrane barrier in EMS on the periapical bone healing will be studied. The trial design is an open randomized controlled clinical trial with a 2x2 factorial design. Half of the participants will receive EMS with L-PRF (experimental group), the other half without (control group). The control and experimental group will be divided in 2 subsequent groups: half of the participants will receive an occlusive membrane during EMS, the other half not.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2016-12
• Study Completion: 2020-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Provision of Informed Consent
• Patients in need of an EMS
• EMS is the only option to cure the periapical lesion

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
+ L-PRF	conebeam CT	With leukocyte and platelet rich fibrin
- L-PRF	conebeam CT	Without leukocyte and platelet rich fibrin
+ L-PRF	EMS	With leukocyte and platelet rich fibrin
+ L-PRF	+ occlusive membrane	With leukocyte and platelet rich fibrin
- L-PRF	EMS	Without leukocyte and platelet rich fibrin

Primary Outcome Measures

Name	Time	Method
Patient related outcomes	7 days	Assessed with a Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
Patient related outcomes	7 days	Assessed with a questionnaire

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium