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

NCT05772975 | Completed Phase 3

• 1 other identifier: 02-3-4-59-1-3/2021
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet-Rich Fibrin

Keywords

Molar, Third; PRF; Platelet-Rich Fibrin

Outcome Measures

Primary Outcomes (4)

• The impact of E-PRF vs H-PRF vs Control on soft tissue healing

  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

  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

  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

  Bone healing will be evaluated by comparing digital OPGs i.e. radiographic bone densitiy profiles in extraction sockets will be compared.

  3 months

Secondary Outcomes (7)

• The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth

  1 month

• The impact of E-PRF vs H-PRF vs Control on periodontal pocket depth

  3 months

• The impact of E-PRF vs H-PRF vs Control on postoperative trismus

  3 days

• The impact of E-PRF vs H-PRF vs Control on postoperative trismus

  7 days

• The impact of E-PRF vs H-PRF vs Control on postoperative swelling

  3 days

Study Arms (3)

E-PRF

EXPERIMENTAL

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

H-PRF

EXPERIMENTAL

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)

CONTROL

NO INTERVENTION

After the impacted mandibular third molar has been surgically removed, the wound is primarily closed.

Interventions

H-PRF (Horizontal-platelet rich fibrin) 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.

H-PRF

E-PRF 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.

E-PRF

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amila Haskic: lead

Study Sites (1)

Faculty of Dentistry with Dental Clinical Center

Sarajevo, Federation of Bosnia and Herzegovina, 71000, Bosnia and Herzegovina

Location

Study Officials

• Amila Haskic

  University of Sarajevo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 17, 2023
• Study Start: May 21, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)