Endodontic Microsurgery With the Use of L-PRF Block

Apical Periodontitis Clinical Trial

Official title:

Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379010
• Other study ID #: S63971
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Nastaran Meschi, PhD
• Phone: 0032476313889
• Email: Nastaran.meschi[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of peri-apical bone healing	Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).	1 year
Secondary	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
Secondary	Patient related outcomes	Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op.	7 days
Secondary	Patient related outcomes	Discomfort assessed with a Visual Analogue Scale ranging from 1 to 5 each day during the first 7 days post-op.	7 days
Secondary	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.	1 year
Secondary	Success & survival rate	Success & survival rate	1 year
Secondary	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.	1 year