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Endodontic Microsurgery With the Use of L-PRF Block

Primary Purpose

Apical Periodontitis, Apical Periodontal Cyst

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Endodontic Microsurgery
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Provision of Informed Consent
  • Patients from 18 years old
  • Patients in need of an EMS
  • EMS is the only option to cure the periapical lesion
  • A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT

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
  • Hepatitis B or C
  • Systemic disease (osteoporosis, diabetes…)

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With L-PRF Block

No L-PRF Block

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient related outcomes
Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op.
Patient related outcomes
Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op.
Patient related outcomes
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
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
Success & survival rate
Dentinal defects
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.

Full Information

First Posted
April 22, 2022
Last Updated
September 14, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05379010
Brief Title
Endodontic Microsurgery With the Use of L-PRF Block
Official Title
Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Apical Periodontal Cyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With L-PRF Block
Arm Type
Experimental
Arm Title
No L-PRF Block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endodontic Microsurgery
Intervention Description
Surgical removal of 3 millimeters of the root-end, removal of the apical pathology, Root-end preparation and retrograde filling. The entire procedure is done under magnification.
Primary Outcome Measure Information:
Title
Amount of peri-apical bone healing
Description
Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient related outcomes
Description
Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op.
Time Frame
7 days
Title
Patient related outcomes
Description
Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op.
Time Frame
7 days
Title
Patient related outcomes
Description
Discomfort assessed with a Visual Analogue Scale ranging from 1 to 5 each day during the first 7 days post-op.
Time Frame
7 days
Title
Bone or scar tissue healing
Description
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.
Time Frame
1 year
Title
Success & survival rate
Description
Success & survival rate
Time Frame
1 year
Title
Dentinal defects
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Provision of Informed Consent Patients from 18 years old Patients in need of an EMS EMS is the only option to cure the periapical lesion A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT 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 Hepatitis B or C Systemic disease (osteoporosis, diabetes…)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nastaran Meschi, PhD
Phone
0032476313889
Ext
+32
Email
Nastaran.meschi@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Joëy d'Hoop, DDS
Phone
0032477362532
Email
Joey.dhoop@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nastaran Meschi, DDS
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Endodontic Microsurgery With the Use of L-PRF Block

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