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

September 13, 2018 updated by: Mehmet Gagari Caymaz, Near East University, Turkey

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1st day after the operation.
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).
2nd day after the operation.
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).
3rd day after the operation.
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).
7th day after the operation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Analgesics Taken by the Patients
Time Frame: Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.
Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.
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
Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.
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
Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Near East University, Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mehmet G Caymaz, DDS, Near East University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Near East University (Other Identifier: Near East Universıty)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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