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

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06262945
• Other study ID #: YDU/2024/120-1808
• Status: Completed
• Start date: January 2, 2024
• Est. completion date: February 7, 2024

Study information

• Verified date: February 2024
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 7, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

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

Procedure:
• traditional osteotomies
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).

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.

Drug:
• Antibiotics, Penicillin
Antibiotics are prescribed for the patients.

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.

Drug:
• Analgesic
Analgesics are prescribed for the patients.

Locations

Country	Name	City	State
Cyprus	Near East University	Nicosia	Lefkosa

Sponsors (1)

Lead Sponsor	Collaborator
Beste Erismen

Country where clinical trial is conducted

Cyprus, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 1
Primary	Visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 2
Primary	Visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 3
Primary	Visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 7
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 1
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 2
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 3
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 7
Primary	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
Primary	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
Primary	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
Primary	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	the number of analgesic tablets		Day 1
Secondary	the number of analgesic tablets		Day 2
Secondary	the number of analgesic tablets		Day 3
Secondary	the number of analgesic tablets		Day 7