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Completed

NCT Number: NCT06900036

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

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.

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Key information

Conditions

Alveolar Bone Resorption Preserving the Alveolar Ridge

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Catolica de Cuenca

Cuenca, Azuay, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation

Procedure

This intervention involves the application of platelet-rich fibrin (PRF) in the extraction socket following premolar extraction to assess its effectiveness in alveolar bone preservation. PRF is a biological autologous material derived from the patient's own blood, promoting bone regeneration, wound healing, and tissue repair.

Primary outcomes

  1. Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT

    Time frame: 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 outcomes

  1. Change in alveolar bone depth (mm) at 1 mm, 3 mm, and 5 mm from crest, at 30 and 120 days post-extraction

    Time frame: 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.

  2. Bone tissue density (HU) at 30 and 120 days post-extraction measured via CBCT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Católica de Cuenca

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

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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