Investigation of the Effects of H-PRF on the Period After Impacted Third Molar Tooth Extraction

NCT06244797 | Completed Results

• 1 other identifier: 23-KAEK-146
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

After wisdom teeth are extracted, the patient may have some complaints in the post-operative period. Pain, swelling and edema are some of them. These inflammatory complications are important for patients and surgeons to reduce the risk of complications and ensure postoperative recovery and develop customized strategy. Many studies have been conducted in the literature to minimize these situations encountered after tooth extraction.

Conditions

Impacted Third Molar Tooth

Keywords

Impacted Third Molar Tooth, PRF

Outcome Measures

Primary Outcomes (2)

• Postoperative Facial Swelling (Sum of 3 Linear Distances, mm)

  Swelling was evaluated by measuring three linear facial distances: LC-M (lateral canthus to mandibular angle), T-CL (tragus to labial commissure), and T-P (tragus to soft tissue pogonion). The sum of these distances (in mm) was calculated for each participant preoperatively and on postoperative Days 2 and 7. Mean values are reported. Higher values indicate greater swelling. Time Frame: Postoperative Day 2 and Day 7 Unit of Measure: Millimeters (mm) Measure Type: Mean Measure of Dispersion/Precision: Standard Deviation

  Postoperative day 2 and day 7

• Maximum Interincisal Distance (Mouth Opening, mm)

  Trismus was assessed by measuring the maximum interincisal distance (mouth opening) with a calibrated ruler. Measurements were recorded on postoperative Days 2 and 7. Lower values indicate more restricted mouth opening.

  postoperative day 2 and day 7

Secondary Outcomes (5)

• Soft Tissue Healing (Landry Index, 5-point Scale)

  Postoperative Day 2 and Day 7

• Postoperative Pain (Visual Analog Scale, 0-10)

  6 hours after surgery and postoperative Days 1 through 7

• Oral Health-Related Quality of Life (Majid Questionnaire, Total Score 0-42)

  Postoperative Day 4

• Oral Health-Related Quality of Life (Majid Questionnaire Subscales; Days With Symptoms, 0-7)

  Postoperative Day 7

• Oral Health-Related Quality of Life (Majid - Eating & Drinking; Days With Symptoms, 0-7)

  Postoperative Day 7

Study Arms (3)

CONTROL GROUP

PLACEBO COMPARATOR

Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.

Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal

L-PRF (leukocyte-platelet rich fibrin):

ACTIVE COMPARATOR

The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.

Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal

H-PRF (horizontal-platelet rich fibrin)

ACTIVE COMPARATOR

The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.

Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal

Interventions

L-PRF and H-PRF PROCEDURE

Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.

CONTROL GROUP; H-PRF (horizontal-platelet rich fibrin); L-PRF (leukocyte-platelet rich fibrin):

Impacted Tooth Removal PROCEDURE

All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.

CONTROL GROUP; H-PRF (horizontal-platelet rich fibrin); L-PRF (leukocyte-platelet rich fibrin):

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer ASA I individuals between the ages of 18-40

You may not qualify if:

• Those who are pregnant or lactating
• Those receiving anticoagulant or antiplatelet drug therapy
• Those who received radiotherapy to the head and face area
• Those who are allergic to local anesthetics and prescribed medications

Sponsors & Collaborators

• esengul sen: lead

Study Sites (1)

Tokat Gaziosmanpaşa Üniversitesi

Tokat Province, Kaleardı Neighbourhood, Turkey (Türkiye)

Location

Related Publications (2)

• Majid OW. Submucosal dexamethasone injection improves quality of life measures after third molar surgery: a comparative study. J Oral Maxillofac Surg. 2011 Sep;69(9):2289-97. doi: 10.1016/j.joms.2011.01.037. Epub 2011 Apr 22.

  PMID: 21514710 BACKGROUND

• Landry RG, Turnbull RS, Howley T: Effectiveness of benzydamyne HCl in the treatment of periodontal post- surgical patients. Res Clin Forums. 1988, 10:105-18

  BACKGROUND

Results Point of Contact

• Title: Dr.Esengul Sen
• Organization: Dr.Lecturer

esengulbekar@gop.edu.tr

05549852255

Study Officials

• Esengül ŞEN

  Tokat Gaziosmanpasa University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant Prof. DDS, Phd, Head of Oral and Maxillofacial Surgery Department

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 6, 2024
• Study Start: December 18, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 14, 2024
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)