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

NCT03672669 | Completed

• 1 other identifier: Near East University
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Trismus; Swelling

Keywords

Leukocyte- and platelet rich fibrin; Advanced platelet rich fibrin; Impacted mandibular third molar surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Number of Analgesics Taken by the Patients

  Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.

• Trismus

  Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.

• Swelling on the cheek

  Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.

Study Arms (2)

Advanced Platelet Rich Fibrin (A-PRF)

ACTIVE COMPARATOR

A-PRF was applied into the tooth socket after mandibular third molar surgery.

Genetic: Advanced Platelet Rich Fibrin (A-PRF)

Leukocyte- and platelet-rich fibrin (L-PRF)

ACTIVE COMPARATOR

L-PRF was applied into the tooth socket after mandibular third molar surgery.

Genetic: Leukocyte- and platelet-rich fibrin (L-PRF)

Interventions

Advanced Platelet Rich Fibrin (A-PRF) GENETIC

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

Advanced Platelet Rich Fibrin (A-PRF)

Leukocyte- and platelet-rich fibrin (L-PRF) GENETIC

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

Leukocyte- and platelet-rich fibrin (L-PRF)

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University

Mersin, 99138, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Trismus

Interventions

Leukocyte Count

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System 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

Study Officials

• Mehmet G Caymaz, DDS

  Near East University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: patients with bilateral impacted mandibular third molar which surgically operated at different times

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: November 5, 2017
• Primary Completion: March 1, 2018
• Study Completion: May 20, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

TU (1)