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

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 Overview

• Status: Completed
• Conditions: Periapical Periodontitis
• Intervention / Treatment: Procedure: EMS; Device: + occlusive membrane; Device: conebeam CT

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: + L-PRF; With leukocyte and platelet rich fibrin	Procedure: EMS; Device: + occlusive membrane; Device: conebeam CT
Active Comparator: - L-PRF; Without leukocyte and platelet rich fibrin	Procedure: EMS; Device: conebeam CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient related outcomes	Assessed with a Visual Analog Scale	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient related outcomes	Assessed with a questionnaire	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of periapical bone healing in time	Assessed with conebeam CT and periapical radiography	4 years
Timeframe in which the cortical bone plate closes	Assessed with echography	1 year
Bone or scar tissue healing	Assessed with conebeam CT	4 years
Dentinal defects	Assessed with a LED light source	1 day
Type of periapical tissue	Assessed by biopsy	7 days

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: platelets
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: S58015 / B322201525314/ I / U