Clinical trial NCT06900036: Radiographic Evaluation in Alveolar Preservation Using Platelet-rich Fibrin. Randomized Controlled Trial
Official title: Radiographic Evaluation in Alveolar Preservation Using Platelet-rich Fibrin. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Resorption
Preserving the Alveolar Ridge
Keywords: Bone Regeneration
Tooth Socket
oral surgery
Platelet-rich fibrin
CBCT
Lead sponsor: Universidad Católica de Cuenca
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 17
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT
timeFrame: Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.
Secondary outcomes:
measure: Change in alveolar bone depth (mm) at 1 mm, 3 mm, and 5 mm from crest, at 30 and 120 days post-extraction
timeFrame: Baseline, 30 days, and 120 days post-extraction.
measure: Bone tissue density (HU) at 30 and 120 days post-extraction measured via CBCT
timeFrame: Baseline, 30 days, and 120 days post-extraction.
Other outcomes:
Locations:
city: Cuenca
country: Ecuador
facility: Universidad Catolica de Cuenca
state: Azuay
Study officials:
affiliation: Universidad Católica de Cuenca
name: ROCIO MAGDALENA MOLINA BARAHONA, Doctor of Dental Surgery (DDS)
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica de Cuenca
name: RENATA A AVECILLAS RODAS, Doctor of Dental Surgery (DDS)
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.