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Clinical Trials/NCT06244797
NCT06244797CompletedNot Applicable

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

esengul sen1 site in 1 country75 target enrollmentStarted: December 18, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
Postoperative Facial Swelling (Sum of 3 Linear Distances, mm)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: L-PRF and H-PRF (Procedure)

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.

Intervention: L-PRF and H-PRF (Procedure)

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.

Intervention: Impacted Tooth Removal (Procedure)

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.

Intervention: L-PRF and H-PRF (Procedure)

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.

Intervention: Impacted Tooth Removal (Procedure)

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.

Intervention: Impacted Tooth Removal (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: Postoperative day 2 and day 7

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

Maximum Interincisal Distance (Mouth Opening, mm)

Time Frame: postoperative day 2 and day 7

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
esengul sen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

esengul sen

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

Tokat Gaziosmanpasa University

Study Sites (1)

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