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

Phase 2

Active, not recruiting

• Conditions: Periapical Lesions

• Registration Number: NCT06734962
• Lead Sponsor: Riga Stradins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-12
• Primary Completion: 2022-09-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volumetric bone volume healing assessment	Baseline, 6 and 12 month	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.

Secondary Outcome Measures

Name	Time	Method
Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment	Baseline	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.

Trial Locations

Locations (1)

Riga Stradins University Institute of Stomatology; 🇱🇻 Riga, Latvia