Impacted Third Molar ToothNCT06262945
Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery.
An observational study of Impacted Third Molar Tooth, run by Beste Erismen at 1 site in Cyprus.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Diagnoses, traditional osteotomies and platelet rich fibrin
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 2 Jan 2024to 7 Feb 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: community aged between 18-40 without any important systemic disease.
Who may be able to join
- 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.
Who cannot join
- pericoronitis, no inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Diagnoses, traditional osteotomies, platelet rich fibrin, Antibiotics, Penicillin, low laser therapy, bicure laser
- Keywords
- platelet rich fibrin, comparison, low laser therapy, wisdom tooth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosesDiagnostic test
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
traditional osteotomiesProcedure or surgery
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
platelet rich fibrinBiological
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.
Antibiotics, PenicillinDrug
Antibiotics are prescribed for the patients.
low laser therapy, bicure laserDevice
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.
AnalgesicDrug
Analgesics are prescribed for the patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | platelet rich fibrin placed into the socket of the extraciton tooth + Augmentin 1gr tablet prescribed 2 times a day Receives: Diagnostic Test: Diagnoses; Procedure: traditional osteotomies; Biological: platelet rich fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic | |
| 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 Receives: Diagnostic Test: Diagnoses; Procedure: traditional osteotomies; Biological: platelet rich fibrin; Drug: Antibiotics, Penicillin; Device: low laser therapy, bicure laser; Drug: Analgesic | |
| 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 Receives: Diagnostic Test: Diagnoses; Procedure: traditional osteotomies; Drug: Antibiotics, Penicillin; Device: low laser therapy, bicure laser; Drug: Analgesic | |
| Control group. | Tradional osteomy was made. + Augmentin 1gr tablet prescribed 2 times a day Receives: Diagnostic Test: Diagnoses; Procedure: traditional osteotomies; Drug: Antibiotics, Penicillin; Drug: Analgesic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: Day 1
Visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: Day 2
Visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: Day 3
Visual analogue scale (VAS)
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: Day 7
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: Day 1
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: Day 2
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: Day 3
Trismus
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Measured: Day 7
Swelling
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.
Measured: Day 1
Swelling
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.
Measured: Day 2
Swelling
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.
Measured: Day 3
Swelling
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.
Measured: Day 7
Secondary outcomes (4)
the number of analgesic tablets
Measured: Day 1
the number of analgesic tablets
Measured: Day 2
the number of analgesic tablets
Measured: Day 3
the number of analgesic tablets
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start2 Jan 2024
- Primary completion6 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beste Erismen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beste Erismen, Near East University, Turkey
- Investigators
- Beste Erismen Agan, Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262945
- Sponsor's protocol ID
- YDU/2024/120-1808
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16706690Krynicka 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.
PubMed 20203347Donmezer 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.
PubMed 34901267Feslihan 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.
PubMed 31589558Erismen Agan B, Uyanik LO, Donmezer CM. Comparison of the postoperative effect of low laser therapy and platelet rich fibrin on mandibular third molar surgery: a randomized study. BMC Oral Health. 2025 Mar 25;25(1):427. doi: 10.1186/s12903-025-05828-3.
PubMed 40134000
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Examination of the Postoperative Effects of Low-laser Treatment and Platelet-rich Fibrin Applications After Mandibular Impacted Wisdom Teeth Extraction
- ClinicalTrials.gov ID
- NCT06262945
- Acronym / sponsor ID
- YDU/2024/120-1808
- Conditions
- Impacted Third Molar Tooth
- Keywords
- platelet rich fibrin, comparison, low laser therapy, wisdom tooth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beste ErismenUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 16 Feb 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Diagnoses, Procedure: traditional osteotomies, Biological: platelet rich fibrin, Drug: Antibiotics, Penicillin, Drug: Analgesicplatelet rich fibrin placed into the socket of the extraciton tooth + Augmentin 1gr tablet prescribed 2 times a day |
| Group 2 | – | Diagnostic Test: Diagnoses, Procedure: traditional osteotomies, Biological: platelet rich fibrin, Drug: Antibiotics, Penicillin, Device: low laser therapy, bicure laser, Drug: Analgesicplatelet 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 |
| Group 3 | – | Diagnostic Test: Diagnoses, Procedure: traditional osteotomies, Drug: Antibiotics, Penicillin, Device: low laser therapy, bicure laser, Drug: AnalgesicLow 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 |
| Control group. | – | Diagnostic Test: Diagnoses, Procedure: traditional osteotomies, Drug: Antibiotics, Penicillin, Drug: AnalgesicTradional osteomy was made. + Augmentin 1gr tablet prescribed 2 times a day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community aged between 18-40 without any important systemic disease.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- pericoronitis, no inflammation
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 |
|---|---|---|
| DiagnosesAll of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant. | Diagnostic test | Control group., Group 1, Group 2, Group 3 |
| traditional osteotomiesIn all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap). | Procedure or surgery | Control group., Group 1, Group 2, Group 3 |
| platelet rich fibrinPlatelet 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. | Biological | Group 1, Group 2 |
| Antibiotics, PenicillinAntibiotics are prescribed for the patients. | Drug | Control group., Group 1, Group 2, Group 3 |
| low laser therapy, bicure laserThere 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. | Device | Group 2, Group 3 |
| AnalgesicAnalgesics are prescribed for the patients. | Drug | Control group., Group 1, Group 2, Group 3 |
Primary outcome
Visual analogue scale (VAS)
Time frame: Day 1
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Visual analogue scale (VAS)
Time frame: Day 2
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Visual analogue scale (VAS)
Time frame: Day 3
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Visual analogue scale (VAS)
Time frame: Day 7
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
the number of analgesic tablets
Time frame: Day 1
the number of analgesic tablets
Time frame: Day 2
the number of analgesic tablets
Time frame: Day 3
the number of analgesic tablets
Time frame: Day 7
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 16 Feb 2024.
- Background: PubMed 16706690Desmet 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.
- Background: PubMed 20203347Krynicka 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.
- Background: PubMed 34901267Donmezer 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.
- Background: PubMed 31589558Feslihan 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.
- Derived from this study: PubMed 40134000Erismen Agan B, Uyanik LO, Donmezer CM. Comparison of the postoperative effect of low laser therapy and platelet rich fibrin on mandibular third molar surgery: a randomized study. BMC Oral Health. 2025 Mar 25;25(1):427. doi: 10.1186/s12903-025-05828-3.
- Individual participant dataSharing planned: No
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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.
Beste Erismen Agan 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?
An observational study of Impacted Third Molar Tooth, run by Beste Erismen at 1 site in Cyprus.
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 1 inclusion and 1 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 16 Feb 2024. 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 Cyprus. 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?
Visual analogue scale (VAS) (time frame: Day 1). The study lists 12 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 NCT06262945, which also lists 5 linked publications.
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 16 Feb 2024.