Radiographic Evaluation in Alveolar Preservation Using Platelet-rich Fibrin. Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Patients taking medications that interfere with healing (e.g., bisphosphonates, corticosteroids, anticoagulants).
Arms & Interventions
Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation
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.
Intervention: Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation (Procedure)
Control Group - Natural Healing (No PRF Application)
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.
Outcomes
Primary Outcomes
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
- 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.)
Investigators
ROCIO MAGDALENA MOLINA BARAHONA
Oral and Maxillofacial Radiologist
Universidad Católica de Cuenca