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Impacted Third Molar ToothNCT06244797

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

A study testing L-PRF and H-PRF and Impacted Tooth Removal in people with Impacted Third Molar Tooth, run by esengul sen at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Impacted Third Molar Tooth
What is being tested?
L-PRF and H-PRF and Impacted Tooth Removal
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Dec 2023to 14 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Tokat Gaziosmanpaşa Üniversitesi

    Tokat Province, Kaleardı Neighbourhood

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the 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.

Being tested
L-PRF and H-PRF, Impacted Tooth Removal
Keywords
Impacted Third Molar Tooth, PRF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-PRF and H-PRFProcedure or surgery

    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 RemovalProcedure or surgery

    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.

Study groups in NCT06244797
Study groupRoleWhat they receive
CONTROL GROUPPlacebo comparatorPatient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
Receives: Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal
L-PRF (leukocyte-platelet rich fibrin):Active comparatorThe 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.
Receives: Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal
H-PRF (horizontal-platelet rich fibrin)Active comparatorThe 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.
Receives: Procedure: L-PRF and H-PRF; Procedure: Impacted Tooth Removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Postoperative day 2 and day 7

  2. 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.

    Measured: postoperative day 2 and day 7

Secondary outcomes (5)

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

    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.

    Measured: Postoperative Day 2 and Day 7

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

    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.

    Measured: 6 hours after surgery and postoperative Days 1 through 7

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

    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).

    Measured: Postoperative Day 4

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

    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.

    Measured: Postoperative Day 7

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

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

    Measured: Postoperative Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2024
  2. Study start18 Dec 2023
  3. Primary completion1 Mar 2024
  4. Study completion14 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244797
Sponsor's protocol ID
23-KAEK-146
Status last verified
Jan 2026
First submitted
11 Jan 2024
Last updated
23 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21514710

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing L-PRF and H-PRF and Impacted Tooth Removal in people with Impacted Third Molar Tooth, run by esengul sen at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Facial Swelling (Sum of 3 Linear Distances, mm) (time frame: Postoperative day 2 and day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06244797, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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