An interventional study of Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation in Alveolar Bone Resorption and Preserving the Alveolar Ridge, sponsored by Universidad Católica de Cuenca. Completed at 1 site in Ecuador. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Universidad Católica de Cuenca · Not applicable, Interventional, and Prevention
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.
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.
167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.
This study's enrollment of 17 is below the median of 24 across 146 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →Universidad Católica de Cuenca is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.
Change in alveolar bone depth (mm) at 1 mm, 3 mm, and 5 mm from crest, at 30 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.
Time frame: Baseline, 30 days, and 120 days post-extraction.
Bone tissue density (HU) at 30 and 120 days post-extraction measured via CBCT
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.
Time frame: Baseline, 30 days, and 120 days post-extraction.
Plan to share: Yes — Radiographic CBCT images (de-identified) Clinical measurements (bone height, depth, and quality) Demographic information (age, sex, general health status) Outcome measures (PRF effectiveness in alveolar preservation) Access Criteria: Available to qualified researchers upon request Requires a formal data access request and institutional agreement Compliance with ethical and privacy regulations Time Frame: Available upon study publication Accessible for at least five years post-publication Storage: Data will be stored in a secure university repository and potentially in public research databases. This plan ensures transparency, collaboration, and compliance with ICMJE guidelines for clinical research.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Ran from Mar 2023 to primary completion in Sep 2023, 6 months.
Of 82 non-industry interventional studies with no phase under Bone Resorption, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 6 months is below that.
Counting every sponsor, half of 83 studies reached it within 23 months; a quarter within 12 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Universidad Católica de Cuenca