Pain, PostoperativeNCT03672669

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

A study testing Advanced Platelet Rich Fibrin (A-PRF) and Leukocyte- and platelet-rich fibrin (L-PRF) in people with Pain, Postoperative and Trismus, run by Near East University, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative, Trismus, Swelling
What is being tested?: Advanced Platelet Rich Fibrin (A-PRF) and Leukocyte- and platelet-rich fibrin (L-PRF)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Nov 2017to 20 May 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 26 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Near East University
Mersin, 99138

Other trials in Turkey (Türkiye)

About this study

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

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
Being tested: Advanced Platelet Rich Fibrin (A-PRF), Leukocyte- and platelet-rich fibrin (L-PRF)
Keywords: Leukocyte- and platelet rich fibrin, Advanced platelet rich fibrin, Impacted mandibular third molar surgery
Medical subject headings: Pain, Postoperative, Trismus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03672669
Study group	Role	What they receive
Advanced Platelet Rich Fibrin (A-PRF)	Active comparator	A-PRF was applied into the tooth socket after mandibular third molar surgery. Receives: 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. Receives: Genetic: Leukocyte- and platelet-rich fibrin (L-PRF)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 7th day after the operation.

Secondary outcomes (3)

Number of Analgesics Taken by the Patients
Measured: 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
Measured: 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
Measured: Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201720 May 2018

First posted14 Sep 2018
Study start5 Nov 2017
Primary completion1 Mar 2018
Study completion20 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Model description: patients with bilateral impacted mandibular third molar which surgically operated at different times
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03672669
Sponsor's protocol ID: Near East University
Status last verified: Sep 2018
First submitted: 11 Sep 2018
Last updated: 14 Sep 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03672669
Acronym / sponsor ID: Near East University
Conditions: Pain, Postoperative, Trismus, Swelling
Keywords: Leukocyte- and platelet rich fibrin, Advanced platelet rich fibrin, Impacted mandibular third molar surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Near East University, TurkeyUniversity, hospital or other
Study start: 5 Nov 2017 (actual)
Primary completion: 1 Mar 2018 (actual)
Study completion: 20 May 2018 (actual)
First posted: 14 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: patients with bilateral impacted mandibular third molar which surgically operated at different times

Arm	Type	Receives
Advanced Platelet Rich Fibrin (A-PRF)	Active comparator	Genetic: Advanced Platelet Rich Fibrin (A-PRF)A-PRF was applied into the tooth socket after mandibular third molar surgery.
Leukocyte- and platelet-rich fibrin (L-PRF)	Active comparator	Genetic: Leukocyte- and platelet-rich fibrin (L-PRF)L-PRF was applied into the tooth socket after mandibular third molar surgery.

Who may qualify

Ages: 18 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Genetic	Advanced Platelet Rich Fibrin (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	Genetic	Leukocyte- and platelet-rich fibrin (L-PRF)

Primary outcome

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).
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).
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).
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).

3 secondary outcomes

Number of Analgesics Taken by the Patients
Time frame: 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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mehmet G Caymaz, DDS principal investigator

Near East University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Scores Evaluted (time frame: 1st day after the operation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03672669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.