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NCT Number: NCT06244797

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

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.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa Üniversitesi

Tokat Province, Kaleardı Neighbourhood, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

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

    Time frame: Postoperative Day 2 and Day 7

    Healing was assessed using the Landry index, a 5-point ordinal scale (1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = excellent). Assessments were performed on postoperative Days 2 and 7 by a blinded examiner. Higher scores indicate better healing.

  2. Postoperative Pain (Visual Analog Scale, 0-10)

    Time frame: 6 hours after surgery and postoperative Days 1 through 7

    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.

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

    Time frame: Postoperative Day 4

    QoL was assessed using the Majid questionnaire (each item 0-3; total range 0-42). Higher scores indicate worse QoL. A total score was calculated only on postoperative Day 4; on Day 7 only subscale scores were analyzed (no total score).

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

    Time frame: Postoperative Day 7

    On postoperative Day 7, Majid questionnaire subscales were recorded as days with symptoms in the past week (possible range 0-7 days for each subscale). Higher values indicate worse QoL. We report median (full range) per arm. No total score was calculated at Day 7.

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

    Time frame: Postoperative Day 7

    On postoperative Day 7, Eating & Drinking difficulty days were recorded (possible range 0-7 days; higher = worse). We report mean ± SD per arm.

Sponsors and collaborators

Lead sponsor

esengul sen

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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