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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672669
• Other study ID #: Near East University
• Status: Completed
• Phase: N/A
• Start date: November 5, 2017
• Est. completion date: May 20, 2018

Study information

• Verified date: September 2018
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 20, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Swelling
• Tooth, Impacted
• Trismus

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Near East University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Number of Analgesics Taken by the Patients		Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.
Secondary	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.
Secondary	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.