Endodontic Microsurgery With the Use of L-PRF Block | NCT05379010

Studies
Endodontic Microsurgery With the Use of L-PRF Block

NCT05379010

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Sep 15, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Apical Periodontitis
Apical Periodontal Cyst

Interventions

Endodontic Microsurgery

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2020Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Oct 31, 2024Estimated

First Submitted Date

Apr 22, 2022

First Submission Date that Met QC Criteria

May 12, 2022

First Posted Date

May 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2023

Last Update Posted Date

Sep 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With L-PRF Block	Experimental		Procedure: Endodontic Microsurgery
No L-PRF Block	Active Comparator		Procedure: Endodontic Microsurgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endodontic Microsurgery	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of peri-apical bone healing	Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).	1 year

Secondary Outcomes

Measure	Description	Time Frame
Patient related outcomes	Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op.	7 days
Patient related outcomes	Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op.

Other Outcomes

Not provided

Eligibility Module

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…)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nastaran Meschi, PhD	Contact	0032476313889	+32	Nastaran.meschi@kuleuven.be
Joëy d'Hoop, DDS	Contact	0032477362532		Joey.dhoop@uzleuven.be

Overall Officials

Name	Affiliation	Role
Nastaran Meschi, DDS	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven	Recruiting	Leuven	Vlaams-Brabant	3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010485	Periapical Periodontitis
D011842	Radicular Cyst

Ancestor Terms

ID	Term
D010483	Periapical Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases

Browse Leaves

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Browse Branches

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