Clinical trial NCT05336578: Anti-inflammatory Effect of Platelet-Rıch Fıbrın
Official title: Comparative Investigation of Anti-inflammatory Effect of Platelet-Rıch Fıbrın After Mandibular Wisdom Tooth Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Complication
Pain, Postoperative
Edema Face
Keywords: platelet-rich-fibrin
edema
Serum markers
trismus
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluated the anti-inflammatory effect of platelet-rich fibrin (PRF) applied to the extraction socket after impacted mandibular third molar surgery with subjective and objective parameters. A total of 48 patients who had fully impacted wisdom teeth in bilateral and similar positions were included in the study. The control group was formed with the standard extraction of the lower third molars, and the PRF group was formed with local PRF application in addition to standard impacted tooth surgery (n=96). The anti-inflammatory activity of PRF on postoperative 2nd and 7th days was evaluated subjectively by clinical parameters and objectively by biochemical parameters.

Subjective parameters were pain assesment, swelling measurements on the face and limitation of mouth opening. Objective data is the analysis of serum values and anti-inflammatory markers in the blood.

Detailed description: Operations All surgical procedures were performed by the same surgeon, with the same flap design and the same surgical technique. 2 ml of a local anesthetic solution containing 40 mg/ml articaine HCl and 0.006 mg/ml epinephrine HCl was used for N. alveolaris inferior and N. buccalis blockage. The mucoperiosteal flap was removed by making a horizontal incision starting from the retromolar region, through horizontally in the buccal, circular around the neck of the mandibular second molar, and continuing vertically at the mesial half of the mandibular second molar tooth. Alveolotomy and/or division of teeth and/or roots were performed with sterile tungsten carbide burs with an electric controlled motor rotating at 20,000 rpm under 0.9% saline irrigation during operation. Roots were removed from the alveoli with the help of a bein elevator placed on the buccal and/or mesial parts of the teeth. After tooth extraction, the bone, soft tissue residues, and debris in the area were removed, and the socket was irrigated with 0.9% saline. In the control group, primary suturing was performed after bleeding control without any application to the extraction socket, while in the PRF group, PRF was applied to the socket just before suturing (Fig 2). All patients were prescribed antibiotics (amoxicillin-clavulanic acid, 1gr, 2x1) (Augmentin-BID, GlaxoSmithKline, London, England), analgesic (Acetaminophen, 500 mg, 3x1) (Parol, Atabay, Istanbul, Turkey) and mouthwash (120 mg %0.12 chlorhexidine gluconate and 150 mg %0.15 benzydamine hydrochloride, 200 ml, 3x1) (Kloroben, Drogsan, Ankara, Turkey) after the surgical procedure.

PRF Preparation Blood sampling was performed through the peripheral antecubital vein by selecting a suitable branule for the patient's vascular structure with a closed vacuum system. PRFs were prepared according to the method of Choukron et al.(2001). 10 ml blood samples were inserted in a centrifuge device (Intra-Lock International Inc., Boca Raton, USA), under 2700 rpm for 12 min using high speed. The platelet-rich fibrin layer remaining between the acellular plasma and red blood cells in the tube was separated with the help of scissors or a scalpel.

Obtaining edema, pain, and serum marker data A visual analog scale (VAS) of 100 mm was given to the patients to determine the severity of pain on the operation day and on the 2nd and 7th postoperative days, with 0 indicating no pain and 100 indicating the worst pain they had ever experienced. In order to evaluate the severity of edema, the tragus - buccal comissura and lateral canthus - gonion distances of the patients were measured using a flexible ruler before the operation and on the 2nd and 7th days postoperatively, and the results were recorded. To evaluate the trismus level, the interincisal distance of the patients was measured with a flexible ruler before the operation and on the 2nd and 7th days postoperatively in both groups. The progression of swelling and trismus was measured in millimeters and evaluated by comparing with the value obtained at baseline14.

For objective data, ESR values were measured using the Vision ESR analyzer (YHLO Biotech Co., Shenzhen, China), and CRP values were measured using the BN II nephelometric analyzer (Siemens Healthcare Diagnostics, Marburg, Germany). IL-6 levels (pg/ml) were determined using the Human IL-6 Elisa Kit (Elabscience Biotechnology Co., Wuhan, China) and TNF-a levels (pg/ml) were determined using the Human TNF-α Elisa Kit (Elabscience Biotechnology Co., was measured using Wuhan, China).

Statistical Evaluation Data were analyzed with the IBM SPSS® V23 (IBM Company, Chicago, IL, United States) package program. Mann-Whitney U test was used to compare non-normally distributed data according to paired groups, and an independent two-sample t-test was used to compare normally distributed data. The significance level was taken as p\<0.05.

Eligibility criteria: Inclusion Criteria:

* not have any systemic disease that will prevent tissue healing
* no history of regular drug use
* no drug allergies
* not smoking
* not being pregnant
* having bilateral mandibular third molar tooth in class II, position B and C position according to Pell \& Gregory classification with the same root form, position and level of impaction
* no signs of abscess, pericoronitis or inflammation before extraction

Exclusion Criteria:

* pregnancy
* having a chronic disease
* having a local infection in the impacted tooth area
* smoking

Primary outcomes:
measure: Edema measurement
timeFrame: 2nd day posoperatively
measure: Edema measurement
timeFrame: 7th day posoperatively
measure: Trismus measurement
timeFrame: 2nd day postoperatively
measure: Trismus measurement
timeFrame: 7th day postoperatively
measure: Pain assesment
timeFrame: 2nd day postoperatively
measure: Pain assesment
timeFrame: 7th day postoperatively
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 2nd day postoperatively
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 7th day postoperatively
measure: C-reactive protein (CRP)
timeFrame: 2nd day postoperatively
measure: C-reactive protein (CRP)
timeFrame: 7th day postoperatively
measure: interleukin 6 (IL-6)
timeFrame: 2nd day postoperatively
measure: interleukin 6 (IL-6)
timeFrame: 7th day postoperatively
measure: tumor necrosis factor-alpha (TNF-α )
timeFrame: 2nd day postoperatively
measure: tumor necrosis factor-alpha (TNF-α )
timeFrame: 7th day postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Merkez
Study officials:
affiliation: Trakya University
name: Nilay Er
role: PRINCIPAL_INVESTIGATOR
References:
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