Endodontic Microsurgery With the Use of L-PRF Block
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2020
CompletedFirst Submitted
Initial submission to the registry
April 22, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedSeptember 15, 2023
September 1, 2023
4.2 years
April 22, 2022
September 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of peri-apical bone healing
Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).
1 year
Secondary Outcomes (6)
Patient related outcomes
7 days
Patient related outcomes
7 days
Patient related outcomes
7 days
Bone or scar tissue healing
1 year
Success & survival rate
1 year
- +1 more secondary outcomes
Study Arms (2)
With L-PRF Block
EXPERIMENTALNo L-PRF Block
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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…)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nastaran Meschi, DDS
UZ Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2022
First Posted
May 18, 2022
Study Start
August 3, 2020
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share