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

NCT ID: NCT06734962

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-12

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Periapical Lesions

Keywords

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Periapical healing Apical Surgery A-PRF Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group (Without A-PRF)

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

Group Type OTHER

Apical surgery without using A-PRF

Intervention Type 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.

Test group ( With A-PRF)

During the surgery procedure A-PRF application is intended.

Group Type EXPERIMENTAL

Apical surgery procedure using A-PRF

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riga Stradins University

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Karkle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Riga Stradins University Institute of Stomatology

Riga, , Latvia

Site Status

Countries

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Latvia

Other Identifiers

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22-2/427/2021

Identifier Type: -

Identifier Source: org_study_id