The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery
NCT ID: NCT05772975
Last Updated: 2024-08-09
Study Results
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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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2021-05-21
2024-01-30
Brief Summary
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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.
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Detailed Description
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The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.
All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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E-PRF
After the impacted mandibular third molar has been surgically removed E-PRF is placed in the dentoalveolar defect and the wound is primarily closed.
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.
H-PRF
After the impacted mandibular third molar has been surgically removed H-PRF is placed in the dentoalveolar defect PRF made with horizontal centrifuge and the wound is primarily closed.
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.
CONTROL
After the impacted mandibular third molar has been surgically removed, the wound is primarily closed.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)
Exclusion Criteria
* Presence of a condition that affects fibrin clot formation
* History of radiation therapy or chemotherapy
* Allergy to penicillin
* Oral contraceptive usage
* Smoking habit
* Status of pregnancy or lactation
* Presence of any acute local infection
* Missing the adjacent second molar or indicated for extraction
16 Years
30 Years
ALL
Yes
Sponsors
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Amila Haskic
OTHER
Responsible Party
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Amila Haskic
Principal Investigator
Principal Investigators
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Amila Haskic
Role: PRINCIPAL_INVESTIGATOR
University of Sarajevo
Locations
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Faculty of Dentistry with Dental Clinical Center
Sarajevo, Federation of Bosnia and Herzegovina, Bosnia and Herzegovina
Countries
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Other Identifiers
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02-3-4-59-1-3/2021
Identifier Type: -
Identifier Source: org_study_id
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