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

NCT06734962 | Active Not Recruiting Phase 2

• 1 other identifier: 22-2/427/2021
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical Lesions

Keywords

Periapical healing; Apical Surgery; A-PRF; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment

  Baseline

Study Arms (2)

Control group (Without A-PRF)

OTHER

During the surgery procedure A-PRF application is not intended.

Procedure: Apical surgery without using A-PRF

Test group ( With A-PRF)

EXPERIMENTAL

During the surgery procedure A-PRF application is intended.

Procedure: Apical surgery procedure using A-PRF

Interventions

Apical surgery procedure using A-PRF PROCEDURE

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.

Test group ( With A-PRF)

Apical surgery without using A-PRF PROCEDURE

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.

Control group (Without A-PRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients younger than 18 years
• Patients with lesions unrelated to the root apical area
• Patients in possession of vital teeth with radiolucency in the apical region
• Pregnant patients
• Patients with non-restorable teeth
• Patients with advanced periodontal disease
• Patients with uncontrolled systemic health conditions
• Patients receiving bisphosphonate therapy
• Patients receiving orthodontic treatment.

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

Riga Stradins University Institute of Stomatology

Riga, LV-1007, Latvia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 16, 2024
• Study Start: September 12, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

LA (1)