Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar

Comparison of the Effect of Advanced Platelet-rich Fibrin and Leukocyte- and Platelet-rich Fibrin on Outcomes After Removal of Impacted Mandibular Third Molar: A Randomised Split-mouth Study

In this study, it was aimed to investigating and comparing the postoperative effects of leukocyte- and platelet-rich fibrin (L-PRF) and advanced platelet-rich fibrin (A-PRF) in terms of pain, swelling on the cheek, and trismus after mandibular third molar surgery. The study included a total of 27 patients with bilateral impacted mandibular third molar which surgically operated at different times. Patients were evaluated in two randomly separated groups. For the first group; A-PRF and for the second group; L-PRF was applied into the tooth socket. The outcomes variables were; pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed on the basis of; 1st, 2nd, 3rd and 7th days following the operation.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Trismus; Swelling
• Intervention / Treatment: Genetic: Advanced Platelet Rich Fibrin (A-PRF); Genetic: Leukocyte- and platelet-rich fibrin (L-PRF)

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey, 99138
    • Near East University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age≥18
• the presence of bilaterally symmetrically impacted mandibular third molar, which requires an extraction for prophylactic reasons
• absence of systemic diseases
• absence of chronic opioid taken;
• not being pregnant
• not smoking and no alcohol usage
• the absence of allergy to penicillin or any other drugs used during standardized postoperative therapy.

Exclusion Criteria:

• tooth needed to be sectioning during the operation
• operation time exceeding 30 minutes
• the cases with severe periodontal disease or acute pericoronitis,
• the cases using antibiotics for an existing infection
• the cases not capable of following postoperative instructions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Advanced Platelet Rich Fibrin (A-PRF); A-PRF was applied into the tooth socket after mandibular third molar surgery.	Genetic: Advanced Platelet Rich Fibrin (A-PRF); blood samples collected in 10 ml of vacuumed plain glass tubes were centrifuged for 14 minutes at 1500 rpm without anticoagulant agents in order to obtain A-PRF
ACTIVE_COMPARATOR: Leukocyte- and platelet-rich fibrin (L-PRF); L-PRF was applied into the tooth socket after mandibular third molar surgery.	Genetic: Leukocyte- and platelet-rich fibrin (L-PRF); blood samples collected in 10 ml of glass coated plastic tubes were centrifuged without anticoagulant agents for 10 minutes in order to obtain L-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores Evaluted	For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).	1st day after the operation.
Pain Scores Evaluted	For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).	2nd day after the operation.
Pain Scores Evaluted	For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).	3rd day after the operation.
Pain Scores Evaluted	For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).	7th day after the operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Analgesics Taken by the Patients		Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.
Trismus	Trismus was assessed by measuring the distance between the mesioincisal corner of the maxillary and mandibular right incisors while mouth was fully opened	Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.
Swelling on the cheek	In order to record swelling, a modification of the tape measurement method	Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.

Collaborators and Investigators

• Sponsor: Near East University, Turkey
• Investigators: Principal Investigator: Mehmet G Caymaz, DDS, Near East University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2017
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): May 20, 2018

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Advanced platelet rich fibrin; Leukocyte- and platelet rich fibrin; Impacted mandibular third molar surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Neuromuscular Manifestations; Tooth Diseases; Spasm; Pain, Postoperative; Tooth, Impacted; Trismus
• Other Study ID Numbers: Near East University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No