Evaluation of Bone Regeneration After Apical Surgery Using Advanced Platelet-rich Fibrin: Utilization of Ultrasound for the Assessment of Periapical Lesions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Riga Stradins University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Volumetric bone volume healing assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group (Without A-PRF)
During the surgery procedure A-PRF application is not intended.
Intervention: Apical surgery without using A-PRF (Procedure)
Test group ( With A-PRF)
During the surgery procedure A-PRF application is intended.
Intervention: Apical surgery procedure using A-PRF (Procedure)
Outcomes
Primary Outcomes
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
- Asessment of Ultrasound diagnostic accuracy for periapical lesion measurment(Baseline)
Investigators
Aleksandra Karkle
Principal Investigator
Riga Stradins University