Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery.

February 15, 2024 updated by: Beste Erismen

Comparative Examination of the Postoperative Effects of Low-laser Treatment and Platelet-rich Fibrin Applications After Mandibular Impacted Wisdom Teeth Extraction

The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days.

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.
Observational

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.
60

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

  • Cyprus
    • Lefkosa
      • Nicosia, Lefkosa, Cyprus, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

community aged between 18-40 without any important systemic disease.

Description

Inclusion Criteria:

  • The patient had no systemic diseases, no taken opioids for a long period, no current infections or acute pericoronitis, no smoke or drink alcohol, no pregnancy, the absence of allergy to penicillin and presence of penicillin allergy.

Exclusion Criteria:

  • pericoronitis, no inflammation

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group 1
platelet rich fibrin placed into the socket of the extraciton tooth + Augmentin 1gr tablet prescribed 2 times a day
Procedure: traditional osteotomies
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Drug: Antibiotics, Penicillin
Antibiotics are prescribed for the patients.
Drug: Analgesic
Analgesics are prescribed for the patients.
Diagnostic test: Diagnoses
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
Biological: platelet rich fibrin
Platelet rich fibrin (PRF), is an example and popular procedure for accelerate healing of soft and hard tissue because of the presence of various growth factors.a blood sample was taken without anticoagulant in 10 mL glass-coated plastic tubes that were immediately centrifuged (Elektro-mag M415P) at 3,000 rpm for 10 min (approximately 400 g) (13). The platelet-poor plasma that accumulated at the top of the tubes was discarded.PRF was dissected approximately 2 mm below its contact point with the red corpuscles situated beneath, to include any remaining platelets that may have localized below the junction between the PRF and red corpuscles.
Group 2
platelet rich fibrin placed in to the socket of the extractraciton tooth combined with low laser treatment extraorally to the extraction area for three days within surgery day + Augmentin 1gr tablet prescribed 2 times a day
Procedure: traditional osteotomies
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Drug: Antibiotics, Penicillin
Antibiotics are prescribed for the patients.
Drug: Analgesic
Analgesics are prescribed for the patients.
Diagnostic test: Diagnoses
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
Biological: platelet rich fibrin
Platelet rich fibrin (PRF), is an example and popular procedure for accelerate healing of soft and hard tissue because of the presence of various growth factors.a blood sample was taken without anticoagulant in 10 mL glass-coated plastic tubes that were immediately centrifuged (Elektro-mag M415P) at 3,000 rpm for 10 min (approximately 400 g) (13). The platelet-poor plasma that accumulated at the top of the tubes was discarded.PRF was dissected approximately 2 mm below its contact point with the red corpuscles situated beneath, to include any remaining platelets that may have localized below the junction between the PRF and red corpuscles.
Device: low laser therapy, bicure laser
There are studies in the literature that low-energy lasers have positive effects on the biological and biochemical processes of wound healing. Acceleration of local circulation, increase in cell proliferation and collagen synthesis are among the various effects of laser application. B Cure Dental Pro Laser application will be applied to the patient for the first 3 days. Low dose laser application will be applied to the angulus area, covering the surgical area for 8 minutes. Before this laser procedure, the patient will be asked to fill out a pain scale. This pain scale and the number of analgesics used will be monitored for 3 days.
Group 3
Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day + Augmentin 1gr tablet prescribed 2 times a day
Procedure: traditional osteotomies
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Drug: Antibiotics, Penicillin
Antibiotics are prescribed for the patients.
Drug: Analgesic
Analgesics are prescribed for the patients.
Diagnostic test: Diagnoses
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
Device: low laser therapy, bicure laser
There are studies in the literature that low-energy lasers have positive effects on the biological and biochemical processes of wound healing. Acceleration of local circulation, increase in cell proliferation and collagen synthesis are among the various effects of laser application. B Cure Dental Pro Laser application will be applied to the patient for the first 3 days. Low dose laser application will be applied to the angulus area, covering the surgical area for 8 minutes. Before this laser procedure, the patient will be asked to fill out a pain scale. This pain scale and the number of analgesics used will be monitored for 3 days.
Control group.
Tradional osteomy was made. + Augmentin 1gr tablet prescribed 2 times a day
Procedure: traditional osteotomies
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Drug: Antibiotics, Penicillin
Antibiotics are prescribed for the patients.
Drug: Analgesic
Analgesics are prescribed for the patients.
Diagnostic test: Diagnoses
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.

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
Trismus
Time Frame: Day 1
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 1
Trismus
Time Frame: Day 2
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 2
Trismus
Time Frame: Day 3
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 3
Trismus
Time Frame: Day 7
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 7
Visual analogue scale (VAS)
Time Frame: Day 1
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 1
Visual analogue scale (VAS)
Time Frame: Day 2
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 2
Visual analogue scale (VAS)
Time Frame: Day 3
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 3
Visual analogue scale (VAS)
Time Frame: Day 7
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 7
Swelling
Time Frame: Day 1
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Day 1
Swelling
Time Frame: Day 2
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Day 2
Swelling
Time Frame: Day 3
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Day 3
Swelling
Time Frame: Day 7
measured using a flexible plastic measuring tape as described by Gabka and Matsumura by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible.
Day 7

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
Time Frame
the number of analgesic tablets
Time Frame: Day 1
Day 1
the number of analgesic tablets
Time Frame: Day 2
Day 2
the number of analgesic tablets
Time Frame: Day 3
Day 3
the number of analgesic tablets
Time Frame: Day 7
Day 7

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.
Beste Erismen

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: Beste Erismen Agan, Near East University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 2, 2024

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.
February 6, 2024

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.
February 7, 2024

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).
February 8, 2024

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.
February 15, 2024

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.
February 16, 2024

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.
February 16, 2024

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.
February 15, 2024

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.
February 1, 2024

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.
  • YDU/2024/120-1808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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