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

Universitaire Ziekenhuizen KU Leuven56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periapical Periodontitis

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient related outcomes

Assessed with a Visual Analog Scale

Time frame: 7 days

Secondary Outcomes