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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Periapical Periodontitis

Treatments: Device: conebeam CT; Procedure: EMS; Device: + occlusive membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT02528240

S58015 / B322201525314/ I / U

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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56 participants in 2 patient groups

+ L-PRF

Experimental group

Description:

With leukocyte and platelet rich fibrin

Treatment:

Procedure: EMS

Device: + occlusive membrane

Device: conebeam CT

- L-PRF

Active Comparator group

Description:

Without leukocyte and platelet rich fibrin

Treatment:

Procedure: EMS

Device: conebeam CT