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

March 14, 2023 updated by: Amila Haskic

Evaluation of Soft and Hard Tissue Healing After Impacted Mandibular Third Molar Surgery With the Use of E-PRF and H-PRF - a Randomized Controlled Clinical Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bosnia and Herzegovina
    • Federation Of Bosnia And Herzegovina
      • Sarajevo, Federation Of Bosnia And Herzegovina, Bosnia and Herzegovina, 71000
        • Recruiting
        • Faculty of Dentistry with Dental Clinical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
No Intervention: CONTROL
After the impacted mandibular third molar has been surgically removed, the wound is primarily closed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
Time Frame: 3 days
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
3 days
The impact of E-PRF vs H-PRF vs Control on soft tissue healing
Time Frame: 7 days
Soft tissue healing evaluation will be done by modified Landry, Turnbull and Howley healing index. For each post-extraction site, the following parameters will be evaluated by dichotomic scale (0/1): tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins and suppuration.
7 days
The impact of E-PRF vs H-PRF vs Control on bone regeneration
Time Frame: 1 month
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
1 month
The impact of E-PRF vs H-PRF vs Control on bone regeneration
Time Frame: 3 months
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
Time Frame: 1 month
Pocket depth will be measured using a periodontal probe taken from the margin of the gingiva to the base of the pocket along the distal surface of the mandibular second molar at three points: distobuccal, mid-distal, distolingual- by a single evaluator. Periodontal pocket depth will be measured preoperatively, one month and three months postoperatively
1 month
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth
Time Frame: 3 months
Pocket depth will be measured using a periodontal probe taken from the margin of the gingiva to the base of the pocket along the distal surface of the mandibular second molar at three points: distobuccal, mid-distal, distolingual.
3 months
The impact of E-PRF vs H-PRF vs Control on postoperative trismus
Time Frame: 3 days
The primary outcome is to asses the percentage of trismus after mandibular third molar surgery in study groups vs control. Trismus will be measured as the distance between the upper right and lower right central incisors during maximum mouth opening using digital caliper.
3 days
The impact of E-PRF vs H-PRF vs Control on postoperative trismus
Time Frame: 7 days
The primary outcome is to asses the percentage of trismus after mandibular third molar surgery in study groups vs control. Trismus will be measured as the distance between the upper right and lower right central incisors during maximum mouth opening using digital caliper.
7 days
The impact of E-PRF vs H-PRF vs Control on postoperative swelling
Time Frame: 3 days
The primary outcome is to asses the percentage of swelling after mandibular third molar surgery in study groups vs control. Facial swelling will be evaluated by measuring 3 facial distances: from the tragus to pogonion (TPO), tragus to labial commissure (TCO), and angulus mandibulae to lateral canthus (ACA).
3 days
The impact of E-PRF vs H-PRF vs Control on postoperative swelling
Time Frame: 7 days
The primary outcome is to asses the percentage of swelling after mandibular third molar surgery in study groups vs control. Facial swelling will be evaluated by measuring 3 facial distances: from the tragus to pogonion (TPO), tragus to labial commissure (TCO), and angulus mandibulae to lateral canthus (ACA).
7 days
The impact of E-PRF vs H-PRF vs Control on postoperative pain
Time Frame: 7 days
The primary outcome is to asses the level of pain after mandibular third molar surgery in study groups vs control. A visual analog scale (VAS) will be used to evaluate postoperative pain. A 10-point VAS with a score of 0 equals "no pain" and 10 equals "very severe pain" will be used to asses subjective pain. Patients will be asked to record number of analgesic taken during the monitoring period of 7days.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amila Haskic

Investigators

  • Principal Investigator: Amila Haskic, University of Sarajevo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02-3-4-59-1-3/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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