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

Sponsor

Amila Haskic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05772975

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Platelet-Rich Fibrin	Biological: H-PRF (Horizontal-platelet rich fibrin) Biological: E-PRF	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The impact of E-PRF vs H-PRF vs Control on soft tissue healing [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.
The impact of E-PRF vs H-PRF vs Control on soft tissue healing [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.
The impact of E-PRF vs H-PRF vs Control on bone regeneration [1 month]
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.
The impact of E-PRF vs H-PRF vs Control on bone regeneration [3 months]
Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.

Secondary Outcome Measures

The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth [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
The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth [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.
The impact of E-PRF vs H-PRF vs Control on postoperative trismus [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.
The impact of E-PRF vs H-PRF vs Control on postoperative trismus [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.
The impact of E-PRF vs H-PRF vs Control on postoperative swelling [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).
The impact of E-PRF vs H-PRF vs Control on postoperative swelling [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).
The impact of E-PRF vs H-PRF vs Control on postoperative pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry with Dental Clinical Center	Sarajevo	Federation Of Bosnia And Herzegovina	Bosnia and Herzegovina	71000

Sponsors and Collaborators

Amila Haskic

Investigators

Principal Investigator: Amila Haskic, University of Sarajevo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amila Haskic, Principal Investigator, University of Sarajevo

ClinicalTrials.gov Identifier:

NCT05772975

Other Study ID Numbers:

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

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 17, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amila Haskic, Principal Investigator, University of Sarajevo

Molar, Third

PRF

Platelet-Rich Fibrin

Study Results

No Results Posted as of Mar 17, 2023