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

NCT06900036 | Completed DMC

• 1 other identifier: CEISH - UCACUE - 031
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Resorption; Preserving the Alveolar Ridge

Keywords

Bone Regeneration; Tooth Socket; oral surgery; Platelet-rich fibrin; CBCT

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.

Secondary Outcomes (2)

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

  Baseline, 30 days, and 120 days post-extraction.

Study Arms (2)

Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation

EXPERIMENTAL

This arm involves the application of Platelet-Rich Fibrin (PRF) immediately after premolar extraction to evaluate its effectiveness in preserving alveolar bone structure and enhancing bone regeneration. PRF is a natural, autologous biomaterial obtained from the patient's own blood, promoting wound healing, bone preservation, and tissue regeneration.

Procedure: Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation

Control Group - Natural Healing (No PRF Application)

NO INTERVENTION

This arm represents the control group, where participants undergo standard premolar extraction without the application of platelet-rich fibrin (PRF). This allows for a direct comparison to assess the effectiveness of PRF in preserving alveolar bone and enhancing healing.

Interventions

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.

Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Católica de Cuenca: lead

Study Sites (1)

Universidad Catolica de Cuenca

Cuenca, Azuay, Ecuador

Location

Related Publications (4)

• Simon BI, Von Hagen S, Deasy MJ, Faldu M, Resnansky D. Changes in alveolar bone height and width following ridge augmentation using bone graft and membranes. J Periodontol. 2000 Nov;71(11):1774-91. doi: 10.1902/jop.2000.71.11.1774.

  PMID: 11128929 BACKGROUND

• Anwandter A, Bohmann S, Nally M, Castro AB, Quirynen M, Pinto N. Dimensional changes of the post extraction alveolar ridge, preserved with Leukocyte- and Platelet Rich Fibrin: A clinical pilot study. J Dent. 2016 Sep;52:23-9. doi: 10.1016/j.jdent.2016.06.005. Epub 2016 Jun 20.

  PMID: 27338946 BACKGROUND

• Alzahrani AA, Murriky A, Shafik S. Influence of platelet rich fibrin on post-extraction socket healing: A clinical and radiographic study. Saudi Dent J. 2017 Oct;29(4):149-155. doi: 10.1016/j.sdentj.2017.07.003. Epub 2017 Aug 2.

  PMID: 29033524 BACKGROUND

• Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.

  PMID: 23644909 BACKGROUND

Related Links

• The link contains forms used in the clinical trial on Platelet-Rich Fibrin (PRF) for alveolar preservation, including informed consent templates, clinical evaluation forms, radiographic analysis templates, and randomization records. Due to patient priva

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• ROCIO MAGDALENA MOLINA BARAHONA, Doctor of Dental Surgery (DDS)

  Universidad Católica de Cuenca

  PRINCIPAL INVESTIGATOR

• RENATA A AVECILLAS RODAS, Doctor of Dental Surgery (DDS)

  Universidad Católica de Cuenca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Radiologist

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 28, 2025
• Study Start: March 1, 2023
• Primary Completion: September 28, 2023
• Study Completion: November 20, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date: Upon publication of study results End Date: At least five years post-publication Additional Notes: Data will be made available as soon as the primary results are published in a peer-reviewed journal. Access may be extended beyond five years based on research demand and institutional policies. Researchers requesting access must submit a formal data request and adhere to data-sharing agreements and ethical guidelines.
• Access Criteria: Qualified researchers from academic, research, or healthcare institutions. Investigators conducting meta-analyses or related studies on PRF and alveolar preservation. Researchers with ethical approval and a valid research proposal. Available Data: De-identified CBCT images, clinical measurements (bone height, depth, HU values), demographic data (age, sex, health status), and outcome measures. Study protocol, data collection methods, and statistical analysis plan. Access Process: Submit a formal request detailing research objectives and ethics approval. Sign a data-sharing agreement to ensure ethical use and compliance. Secure data transfer via an encrypted institutional repository. This policy promotes research transparency, collaboration, and ethical data use while protecting participant privacy.

Locations

EC (1)