Radiographic Evaluation in Alveolar Preservation Using Platelet-rich Fibrin. Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Alveolar Bone Resorption; Preserving the Alveolar Ridge

• Registration Number: NCT06900036
• Lead Sponsor: Universidad Católica de Cuenca

Brief Summary

This randomized controlled trial is designed to assess the use of platelet-rich fibrin (PRF), a biomaterial derived from a participant's own blood, in alveolar ridge preservation following premolar extraction for orthodontic purposes. Participants aged 17 to 38 years requiring premolar extractions will be randomly assigned to receive either PRF application or natural healing without intervention. Cone beam computed tomography (CBCT) will be used to evaluate changes in alveolar bone dimensions and density at 30 and 120 days post-extraction. Measurements will be taken at standardized vertical levels (1 mm, 3 mm, and 5 mm apical to the crest) to analyze bone height, width, and density over time.

Detailed Description

This study is a randomized controlled clinical trial designed to investigate the application of platelet-rich fibrin (PRF) in post-extraction sites following orthodontically indicated premolar removals. PRF is prepared from autologous blood and applied to extraction sockets in the experimental group, while the control group undergoes standard physiological healing. Cone beam computed tomography (CBCT) will be used to obtain quantitative data on alveolar bone structure at baseline, 30 days, and 120 days post-extraction. The study will assess changes in bone height, horizontal ridge width at defined depths, and bone tissue density using standardized imaging protocols. This design allows for objective comparison between treated and untreated sites.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2023-09-28
• Study Completion: 2024-11-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Healthy individuals with no systemic diseases.
• Age range: 17 to 38 years old.
• Orthodontic indication for premolar extraction (two maxillary or two mandibular premolars).
• Candidates for orthognathic surgery or extraction of impacted/retained teeth (e.g., third molars with a relationship to critical anatomical structures).
• Clinical justification for CBCT imaging instead of standard radiographic -techniques.

Exclusion Criteria

• Patients with systemic diseases that may alter periodontal therapy outcomes.
• Platelet count below 200,000 mm³.
• Immunosuppressed patients.
• Pregnant or lactating women.
• Smokers.
• Patients taking medications that interfere with healing (e.g., bisphosphonates, corticosteroids, anticoagulants).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT	Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.	Alveolar bone height will be measured from the most apical point of the socket to the crestal margin using CBCT (cone beam computed tomography) scans at baseline (day of extraction), 30 days, and 120 days post-extraction. Measurements will be recorded in millimeters and compared between PRF-treated sites and control sites (no PRF). The mean difference in height over time will be calculated within and between groups.

Secondary Outcome Measures

Name	Time	Method
Change in alveolar bone depth (mm) at 1 mm, 3 mm, and 5 mm from crest, at 30 and 120 days post-extraction	Baseline, 30 days, and 120 days post-extraction.	Bone depth (horizontal ridge width) will be assessed at three standardized vertical levels (1 mm, 3 mm, and 5 mm from the crestal margin) using CBCT imaging. Measurements will be performed bucco-lingually. Data will be reported as mean ± SD per time point and compared between PRF and control groups.
Bone tissue density (HU) at 30 and 120 days post-extraction measured via CBCT	Baseline, 30 days, and 120 days post-extraction.	Bone density will be measured using Hounsfield Units (HU) within the center of the extraction socket. CBCT scans will be analyzed using imaging software calibrated for HU estimation. The average HU values will be compared between PRF-treated and control sockets to assess mineralization and bone quality.

Trial Locations

Locations (1)

Universidad Catolica de Cuenca; 🇪🇨 Cuenca, Azuay, Ecuador