Endodontic Microsurgery With the Use of L-PRF Block

NCT ID: NCT05379010

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2024-10-31

Brief Summary

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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

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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).

Conditions

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Apical Periodontitis Apical Periodontal Cyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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With L-PRF Block

Group Type EXPERIMENTAL

Endodontic Microsurgery

Intervention Type PROCEDURE

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.

No L-PRF Block

Group Type ACTIVE_COMPARATOR

Endodontic Microsurgery

Intervention Type PROCEDURE

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.

Interventions

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Endodontic Microsurgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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…)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nastaran Meschi, DDS

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Nastaran Meschi, PhD

Role: CONTACT

0032476313889 ext. +32

Joëy d'Hoop, DDS

Role: CONTACT

0032477362532

Other Identifiers

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S63971

Identifier Type: -

Identifier Source: org_study_id

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