Evaluation of Bone Regeneration After Apical Surgery Using Advanced Platelet-rich Fibrin: Utilization of Ultrasound for the Assessment of Periapical Lesions (EBRAAPUU)

The study examines the impact of advanced platelet-rich fibrin (A-PRF) on bone regeneration in apical surgery compared to standard methods. It highlights the effectiveness of ultrasound as a diagnostic tool for assessing periapical lesions. Eligible participants were adults with specific periapical lesions following root canal treatment failures. Exclusions included patients outside specific criteria, like those with advanced periodontal disease or undergoing orthodontic treatment. Participants were randomized into two groups: one receiving A-PRF to enhance bone regeneration and a control group without it. Both groups underwent apical surgery under magnification, with different postoperative protocols. The study involved radiological and ultrasonographic evaluations of lesion size and bone healing at baseline, 6 months, and 12 months, alongside blood analyses for Vitamin D and cholesterol level to assess their potential impact on healing.

Study Overview

• Status: Active, not recruiting
• Conditions: Periapical Lesions
• Intervention / Treatment: Procedure: Apical surgery without using A-PRF; Procedure: Apical surgery procedure using A-PRF

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Latvia
  • Riga, Latvia, LV-1007
    • Riga Stradins University Institute of Stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients with precisely defined periapical lesions related to maxillary or mandibular incisors and premolar teeth as a sequel to persistent endodontic infection
2. Patients after root canal treatment/retreatment
3. Patients with or without the sinus tract
4. Patients with root perforations
5. Patients with clinical cases deemed unsuitable for non-surgical endodontic intervention
6. Patients with traumatic lesions clearly indicated for endodontic apical surgery.

Exclusion Criteria:

1. Patients younger than 18 years
2. Patients with lesions unrelated to the root apical area
3. Patients in possession of vital teeth with radiolucency in the apical region
4. Pregnant patients
5. Patients with non-restorable teeth
6. Patients with advanced periodontal disease
7. Patients with uncontrolled systemic health conditions
8. Patients receiving bisphosphonate therapy
9. Patients receiving orthodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group (Without A-PRF); During the surgery procedure A-PRF application is not intended.	Procedure: Apical surgery without using A-PRF; Participants will undergo an apical surgery procedure without using A-PRF. Patients will undergo comprehensive evaluation before the surgery and at follow-ups using clinical, radiological, and ultrasonographic techniques.
Experimental: Test group ( With A-PRF); During the surgery procedure A-PRF application is intended.	Procedure: Apical surgery procedure using A-PRF; Participants will undergo an apical surgery procedure using A-PRF. Before the surgery and at follow-ups, patients will undergo comprehensive evaluation using clinical, radiological, and ultrasonographic techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric bone volume healing assessment	Volumetric analysis of CBCT images will segment the defect in axial, sagittal, and coronal views. Bone volume will be measured in cubic millimeters (mm³) at pre-operative, 6-month, and 12-month follow-ups and compared between each other. Where 0 is - no periapical lesion/periapical lesion healed.	Baseline, 6 and 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment	During the baseline assessment, the dimensions of periapical lesions will be measured in millimeters and using the classification: Category 1: no discernible periapical lesion was identified; Category 2: a periapical lesion was possibly present, however, the distinction was equivocal; Category 3: a periapical lesion was definitively observed. not unequivocal; Category 3: a periapical lesion was definitively observed. These measurements will then be analyzed in relation to images obtained through periapical radiography as well as those from cone beam computed tomography (CBCT). This comparison aims to evaluate the accuracy and reliability of different imaging techniques in assessing the size of periapical lesions.	Baseline

Collaborators and Investigators

• Sponsor: Riga Stradins University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Periapical healing; A-PRF; Apical Surgery
• Other Study ID Numbers: 22-2/427/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No