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

NCT ID: NCT06244797

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2024-05-14

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.

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.

Conditions

Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

L-PRF and H-PRF

Intervention Type: 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.

Impacted Tooth Removal

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

L-PRF and H-PRF

Intervention Type: 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.

Impacted Tooth Removal

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

L-PRF and H-PRF

Intervention Type: 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.

Impacted Tooth Removal

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

esengul sen

OTHER

Sponsor Role: lead

Responsible Party

esengul sen

Assisstant Prof. DDS, Phd, Head of Oral and Maxillofacial Surgery Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Esengül ŞEN

Role: STUDY_DIRECTOR

Tokat Gaziosmanpasa University

Locations

Tokat Gaziosmanpaşa Üniversitesi

Tokat Province, Kaleardı Neighbourhood, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 21514710 (View on PubMed)

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

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

23-KAEK-146

Identifier Type: -

Identifier Source: org_study_id