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

NCT ID: NCT06900036

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-11-20

Brief Summary

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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

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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.

Conditions

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Alveolar Bone Resorption Preserving the Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica de Cuenca

OTHER

Sponsor Role lead

Responsible Party

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ROCIO MAGDALENA MOLINA BARAHONA

Oral and Maxillofacial Radiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica de Cuenca

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

Role: STUDY_CHAIR

Universidad Católica de Cuenca

Locations

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Universidad Catolica de Cuenca

Cuenca, Azuay, Ecuador

Site Status

Countries

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Ecuador

References

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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.

Reference Type BACKGROUND
PMID: 11128929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27338946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29033524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23644909 (View on PubMed)

Related Links

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https://ucacueedu-my.sharepoint.com/:f:/g/personal/rocio_molina_ucacue_edu_ec/EmUsBYq74wZGl8hxBeQ_cgYBc7hO98P4eFXFhnbsqcvzDw?e=WTIKei

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

Other Identifiers

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CEISH - UCACUE - 031

Identifier Type: -

Identifier Source: org_study_id

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