- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262945
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
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Group 1
platelet rich fibrin placed into the socket of the extraciton tooth + Augmentin 1gr tablet prescribed 2 times a day
|
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Antibiotics are prescribed for the patients.
Analgesics are prescribed for the patients.
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
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
|
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Antibiotics are prescribed for the patients.
Analgesics are prescribed for the patients.
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
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.
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
|
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Antibiotics are prescribed for the patients.
Analgesics are prescribed for the patients.
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
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
|
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Antibiotics are prescribed for the patients.
Analgesics are prescribed for the patients.
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
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
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
Investigators
- 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
- Desmet KD, Paz DA, Corry JJ, Eells JT, Wong-Riley MT, Henry MM, Buchmann EV, Connelly MP, Dovi JV, Liang HL, Henshel DS, Yeager RL, Millsap DS, Lim J, Gould LJ, Das R, Jett M, Hodgson BD, Margolis D, Whelan HT. Clinical and experimental applications of NIR-LED photobiomodulation. Photomed Laser Surg. 2006 Apr;24(2):121-8. doi: 10.1089/pho.2006.24.121.
- Krynicka I, Rutowski R, Staniszewska-Kus J, Fugiel J, Zaleski A. The role of laser biostimulation in early post-surgery rehabilitation and its effect on wound healing. Ortop Traumatol Rehabil. 2010 Jan-Feb;12(1):67-79.
- Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.
- Feslihan E, Eroglu CN. Can Photobiomodulation Therapy Be an Alternative to Methylprednisolone in Reducing Pain, Swelling, and Trismus After Removal of Impacted Third Molars? Photobiomodul Photomed Laser Surg. 2019 Nov;37(11):700-705. doi: 10.1089/photob.2019.4696. Epub 2019 Oct 7.
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)
January 2, 2024
Primary Completion (Actual)
February 6, 2024
Study Completion (Actual)
February 7, 2024
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
February 15, 2024
First Posted (Actual)
February 16, 2024
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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