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

Investigation of the Effects of Y-TZF (Horizontal Platelet-Rich Fibrin) on the Period After Impacted Third Molar Tooth Extraction: Randomized Controlled Clinical Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal

Detailed Description

Many studies have been conducted in the literature to minimize these situations encountered after tooth extraction. Various regenerative methods are being developed to reduce these complaints of patients. Regenerative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), laser therapy, steroids, ultrasound, and PRF applications.

PRF(platelet-rich fibrin) application placed in the extraction socket is one of the regenerative methods used to reduce these complaints. PRF has a fibrin structure obtained from natural blood tissue, containing abundant platelets and leukocytes. This fibrin matrix contains various growth factors and cytokines, including growth factor-beta1 (TGF-β1), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), interleukin (IL), as well as platelets and leukocytes. These factors act directly on promoting the proliferation and differentiation of osteoblasts, endothelial cells, chondrocytes, and various fibroblast sources.

It is known that PRF has a beneficial effect in relieving pain and swelling and reducing the incidence of alveolar osteitis after extraction of an impacted lower third molar. Therefore, it is placed in extraction sockets to try to reduce post-operative complications.

PRF applications are also developing in their own right, and one of them is the H-PRF (horizontal PRF) application. Recently, horizontal centrifugation of PRF has been shown to provide better cell layer separation and minimize cell accumulation that prevents uniform cell layer formation on the distal surfaces of centrifuge tubes.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kaleardı Neighbourhood
    • Tokat, Kaleardı Neighbourhood, Turkey
      • Tokat Gaziosmanpaşa Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: CONTROL GROUP; 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; 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.; Procedure: Impacted Tooth Removal; 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.
Active Comparator: L-PRF (leukocyte-platelet rich fibrin): 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; 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.; Procedure: Impacted Tooth Removal; 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.
Active Comparator: H-PRF (horizontal-platelet rich fibrin); 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; 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.; Procedure: Impacted Tooth Removal; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of edema	Before the procedure, the skin will be marked with a marking pen to establish reference points for assessing the degree of swelling following the procedure. A flexible ruler that can be adjusted to fit the curves of the face was used to take measurements. Five reference points-the tragus, labial commissure, soft tissue pogonion, lateral corner of the eye/lateral canthus, and angulus mandible-will be used to take measurements both horizontally and vertically. Preoperatively and on the second and seventh days following surgery, the following measurements and records will be made: the vertical distance from the angulus mandible to the lateral canthus (LC-M), and the horizontal distances from the tragus to the labial commissure (T-CL) and pogonion (T-P). Calculations will be made to determine the variations between the preoperative and postoperative values. The number of edemas will be determined by calculating the percentage changes. Higher scores will be assessed as a worse outcome.	7 days
Assessment of pain:	The patient's pain assessment will be made with a visual analog scale (VAS). According to this evaluation, a line of a certain length is divided into 10 equal parts. 0 = no pain, 5 = moderate pain, and 10 = unbearable pain. This statement will be reported to the patient verbally, and the patient will be asked to mark the severity of his pain on this note. The patient will be asked to mark the severity of pain on the VAS scale at the 6th hour, 24th hour, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day, and how often anti-inflammatory drugs should be used. Higher scores will be assessed as a worse outcome.	7 days
Evaluation of soft tissue:	Postoperative follow-up also includes an evaluation of swelling and soft tissue healing. Any clinical findings that occur within the first 4 days after surgery will be considered swelling. Soft tissue healing will be evaluated according to Landry and Turnbull(1) criteria. These criteria will be used to evaluate the following: suppuration, incision margin, granulation tissue, tissue color, and response to palpation.	7 days
Evaluation of maximum mouth opening:	The maximum mouth opening (MMO) before the operation will be determined as the distance between the right lower and upper right central incisors. MMO will be measured prior to surgery, and on the second and seventh days following surgery, this measurement will be done again. The difference between preoperative and postoperative measurements after surgery will be calculated to determine the postoperative trismus. The value for trismus will be determined by calculating the percentage changes.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Quality of Life	Patients will be asked to answer questions on a survey form prepared by Majid(2), which is a modification of the Posse scale used to assess the severity of post-operative complications on Days 2 and 7 postoperatively. The survey form consists of five sections and a total of 14 questions. The survey asks questions about appearance, speech, sleep, eating and drinking habits, and social isolation.	7 days

Collaborators and Investigators

• Sponsor: esengul sen
• Investigators: Study Director: Esengül ŞEN, Tokat Gaziosmanpasa University

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Impacted Third Molar Tooth, PRF
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: 23-KAEK-146

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
• product manufactured in and exported from the U.S.: Yes