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

U

Universidad Católica de Cuenca

Status

Completed

Conditions

Preserving the Alveolar Ridge
Alveolar Bone Resorption

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06900036
CEISH - UCACUE - 031

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

17 participants in 2 patient groups

Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation
Experimental group
Description:
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.
Treatment:
Procedure: Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation
Control Group - Natural Healing (No PRF Application)
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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