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Completed

NCT Number: NCT03672669

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

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.

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Key information

Conditions

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

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Near East University

Mersin, 99138, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Pain Scores Evaluted

    Time frame: 1st day after the operation.

    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).

  2. Pain Scores Evaluted

    Time frame: 2nd day after the operation.

    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).

  3. Pain Scores Evaluted

    Time frame: 3rd day after the operation.

    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).

  4. Pain Scores Evaluted

    Time frame: 7th day after the operation.

    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).

Secondary outcomes

  1. Number of Analgesics Taken by the Patients

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

  2. Trismus

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

    Trismus was assessed by measuring the distance between the mesioincisal corner of the maxillary and mandibular right incisors while mouth was fully opened

  3. Swelling on the cheek

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

    In order to record swelling, a modification of the tape measurement method

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2018
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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