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The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery

NCT05772975 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-08-09

No results posted yet for this study

Summary

This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are:

Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.

Conditions

  • Platelet-Rich Fibrin

Interventions

BIOLOGICAL

H-PRF (Horizontal-platelet rich fibrin)

Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. it serves as a biological healing matrix by supporting cell migration and cytokine release. H-PRF is obtained by horizontal centrifugation using (Bio-PRF) centrifuge on 700 g force for 8 minutes. This way the cells separate much more efficiently throughout the entire membrane/clot.

BIOLOGICAL

E-PRF

Platelet-rich fibrin is an autologous biomaterial originating from human blood following centrifugation without additives that contains supraphysiological doses of growth factors. In order to extend its resorption period heating method is used. After centrifugation of blood using (Bio-PRF) centrifuge on 700 g force for 8 minutes top layer is heated for 10 minutes at 75°C in BIO-Heat device. When cooled it is mixed with cell rich buffy coat. This way PRF with extended life is obtained.

Sponsors & Collaborators

  • Amila Haskic

    lead OTHER

Principal Investigators

  • Amila Haskic · University of Sarajevo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2024-01-30
Completion
2024-01-30

Countries

  • Bosnia and Herzegovina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772975 on ClinicalTrials.gov