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NCT Number: NCT06734962

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Periapical Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Riga Stradins University Institute of Stomatology

Riga, LV-1007, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Volumetric bone volume healing assessment

    Time frame: 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 outcomes

  1. Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riga Stradins University

Other

Registry information

Acronym: EBRAAPUU

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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