Leukocyte- and Platelet Rich Fibrin (L-PRF) Application in Impacted Mandibular Third Molar Removal Surgery

NCT03357484 | Unknown

• 1 other identifier: PRF third molar
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the influence of leukocyte- and platelet-rich fibrin (L-PRF) on impacted mandibular third molar (IMTM) extraction wound healing, patient postoperative discomfort, and incidence of alveolar osteitis (AO). Thirty patients (18 female, 12 male) who met the inclusion criteria for this split-mouth study underwent bilateral IMTM surgical extractions. Following extraction, randomization was done. One socket received L-PRF, and the other socket served as a regular blood clot control. Postoperatively, the soft tissue healing index (HI), pain according to visual analog scale (VAS), facial swelling using a horizontal and vertical guide, and incidence of AO were evaluated 1, 3, 7, and 14 days after surgery.

Conditions

Pain; Edema; Wound Heal

Keywords

impacted tooth; pain; platelet-rich fibrin; third molar; tooth extraction; wound healing

Outcome Measures

Primary Outcomes (3)

• Pain visual analogue scale (VAS) score change evaluation

  Pain VAS scale consisted of 10 units in combination with a graphic rating scale, where the leftmost score 0 represented absence of pain and the rightmost score 10 indicated the worst possible, unbearable, excruciating pain.

  1st-, 2nd-, 3rd-, 4th-, 5th-, 6th-, and 7th- postoperative day

• Swelling change evaluation

  Facial swelling clinical assessments were performed by a single blinded examiner at baseline (before surgery) and at the 1st-, 3rd-, and 7th-day visits postoperatively at approximately the same time of day. Patients were seated in a relaxed position with the inferior border of the mandible parallel to the floor. Facial swelling in the operation side was evaluated using two facial measurements with nonexpandable tape: * In the vertical dimension, measurement from the lateral canthus of the eye to the pogonion of the mandible was taken; * In the horizontal dimension, the distance from the lower border of the tragus to the mouth commissure on both operated sides was measured. Facial swelling value was taken as the average value of these two measurements. The preoperative measurement was considered as the baseline value.

  1st-, 3rd-, and 7th- postoperative day

• Healing index change evaluation

  Postextractional wound soft tissue healing was evaluated using a modified postextraction wound healing index (HI) \[24\], which considered four parameters: bleeding, suppuration, tissue color, and consistency of the healing tissue. Each parameter involved 3 scoring levels; consequently, the cumulative scoring scale ranged from 4, corresponding to excellent healing, to 12, indicating severely impaired healing. HI was evaluated clinically by the same blinded examiner at the 1st-, 3rd-, 7th-, and 14th- after surgery.

  1st-, 3rd-, 7th-, and 14th- postoperative day

Other Outcomes (1)

• Alveolar osteitis

  2 postoperative weeks

Study Arms (2)

L-PRF

EXPERIMENTAL

Third molar extraction sockets were filled with two leukocyte- and platelet rich fibrin (L-PRF) clots

Procedure: Leukocyte- and platelet rich fibrin

Blood clot

ACTIVE COMPARATOR

Third molar extraction sockets allowed to form a natural blood clot and undergo natural healing

Procedure: Blood clot

Interventions

Leukocyte- and platelet rich fibrin PROCEDURE

Prior to surgery, two 9 ml glass-coated tubes (Intra-Spin, Intra-Lock International, Boca Raton, USA) of patient venous blood were collected. Tubes were transferred to a centrifuge (Andreas Hettich GmbH \& Co.KG, Tuttlingen, Germany) and processed for 12 minutes at 2800 rpm to prepare L-PRF.

L-PRF

Blood clot PROCEDURE

Natural blood clot formed within extraction socket

Blood clot

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients with an age of 18 to 60 years;
• Healthy patients (American Society of Anesthesiologists Physical Status (ASA PS) index ≤ 2);
• Sole bilateral extractions of IMTMs during the same surgery;
• Complete root formation of tooth No. 38 and 48 at radiological examination;
• Absence of acute inflammation and/or infection in the IMTMs area;
• No history of nonsteroidal anti-inflammatory drug (NSAID) use in the past 4 weeks prior to surgery;
• Same-difficulty bilateral IMTM extractions, according to both Pederson and Juodzbalys \& Daugela classifications;
• Signed informed consent.

You may not qualify if:

• Smoking patients;
• IMTM surgery duration difference greater than 10 minutes for each side, seeking to avoid bias;
• Different surgical manipulations taken at each IMTM surgery site;
• Presence of any neoplastic lesion (benign or malignant), clinically or radiologically evaluable, at the site or close to the impacted tooth;
• Presence of any radiolucent lesion \>1 cm at impacted tooth level;
• Absence of the adjacent tooth;
• Systemic conditions or pharmacological treatments altering oral microbiota or immunologic response;
• Alcohol or drug abuse;
• Pregnant or breastfeeding women;
• Lack of compliance by the patient or any other evidence suggesting that the patient was not likely to follow the study protocol.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, 50009, Lithuania

Location

MeSH Terms

Conditions

Pain; Edema; Tooth, Impacted

Interventions

Leukocyte Count; Blood Coagulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hemostasis

Study Officials

• Povilas Daugela, DDS

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Vaidas Grimuta, DDS

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Dalius Sakavicius, DDS, PhD

  Lithuanian University of Health Sciences

  STUDY DIRECTOR

• Juozas Jonaitis, DDS, PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Gintaras Juodzbalys, DDS, PhD

  Lithuanian University of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and Independent Outcomes Assessor were blinded to study groups. Names of participants were coded and known to Principal investigator only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Model Details: Patients who met the inclusion criteria for this split-mouth study underwent bilateral IMTM surgical extractions. Following extraction, randomization was done. One socket received L-PRF, and the other socket served as a regular blood clot control.

Study Record Dates

• First Submitted: November 18, 2017
• First Posted: November 30, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)