NCT06262945

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 8, 2024

Last Update Submit

February 15, 2024

Conditions

Keywords

platelet rich fibrincomparisonlow laser therapywisdom tooth

Outcome Measures

Primary Outcomes (12)

  • Visual analogue scale (VAS)

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    Day 1

  • Visual analogue scale (VAS)

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    Day 2

  • Visual analogue scale (VAS)

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    Day 3

  • Visual analogue scale (VAS)

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly 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.

    Day 1

  • Trismus

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

    Day 2

  • Trismus

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

    Day 3

  • Trismus

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

    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.

    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.

    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.

    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.

    Day 7

Secondary Outcomes (4)

  • the number of analgesic tablets

    Day 1

  • the number of analgesic tablets

    Day 2

  • the number of analgesic tablets

    Day 3

  • the number of analgesic tablets

    Day 7

Study Arms (4)

Group 1

platelet rich fibrin placed into the socket of the extraciton tooth + Augmentin 1gr tablet prescribed 2 times a day

Diagnostic Test: DiagnosesProcedure: traditional osteotomiesBiological: platelet rich fibrinDrug: Antibiotics, PenicillinDrug: 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

Diagnostic Test: DiagnosesProcedure: traditional osteotomiesBiological: platelet rich fibrinDrug: Antibiotics, PenicillinDevice: low laser therapy, bicure laserDrug: 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

Diagnostic Test: DiagnosesProcedure: traditional osteotomiesDrug: Antibiotics, PenicillinDevice: low laser therapy, bicure laserDrug: Analgesic

Control group.

Tradional osteomy was made. + Augmentin 1gr tablet prescribed 2 times a day

Diagnostic Test: DiagnosesProcedure: traditional osteotomiesDrug: Antibiotics, PenicillinDrug: Analgesic

Interventions

DiagnosesDIAGNOSTIC_TEST

All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.

Control group.Group 1Group 2Group 3

In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).

Control group.Group 1Group 2Group 3

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 1Group 2

Antibiotics are prescribed for the patients.

Control group.Group 1Group 2Group 3

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 2Group 3

Analgesics are prescribed for the patients.

Control group.Group 1Group 2Group 3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • pericoronitis, no inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University

Nicosia, Lefkosa, 99138, Cyprus

Location

Related Publications (5)

  • 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.

    PMID: 16706690BACKGROUND
  • 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.

    PMID: 20203347BACKGROUND
  • 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.

    PMID: 34901267BACKGROUND
  • 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.

    PMID: 31589558BACKGROUND
  • Erismen 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.

MeSH Terms

Interventions

DiagnosisPenicillinsAnalgesics

Intervention Hierarchy (Ancestors)

beta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Beste Erismen Agan

    Near East University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd Stıdent

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

January 2, 2024

Primary Completion

February 6, 2024

Study Completion

February 7, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations