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

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

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2024-01-30

Brief Summary

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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.

Detailed Description

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A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.

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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Platelet-Rich Fibrin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

E-PRF

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

H-PRF (Horizontal-platelet rich fibrin)

Intervention Type BIOLOGICAL

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.

Group Type NO_INTERVENTION

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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Orthodontic indication for impacted mandibular third molar surgery
* Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)

Exclusion Criteria

* Presence of systemic disease
* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amila Haskic

OTHER

Sponsor Role lead

Responsible Party

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Amila Haskic

Principal Investigator

Responsibility Role SPONSOR_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

Site Status

Countries

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Bosnia and Herzegovina

Other Identifiers

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02-3-4-59-1-3/2021

Identifier Type: -

Identifier Source: org_study_id

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