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Clinical trial

Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery

ID
Name
YDU/2019/67-774
Description
The aim of this study was investigate the comparison of postoperative effects of local antibiotics mixed with platelet-rich fibrin and postoperative systemic antibiotic applications prescribed for mandibular impacted third molar tooth extraction. The study included a total of 75 patients with impacted mandibular third molar. Patients were evaluated in 5 randomly separated groups. For the first and third group, Platelets Rich Fibrin+ systemic Antibiotics were applied into the tooth socket and for the second and fourth group, Platelets Rich Fibrin + local antibiotics were applied, respectively. There was a control group which only Platelets Rich Fibrin was applied into the socket. 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.
Trial arms
Trial start
2019-03-17
Estimated PCD
2021-02-20
Trial end
2021-02-21
Status
Completed
Treatment
Diagnosis
All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
Arms:
control group, group 1, group 2, group 3, group 4
traditional osteotomies
In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
Arms:
control group, group 1, group 2, group 3, group 4
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.
Arms:
control group, group 1, group 2, group 3, group 4
Antibiotics, Penicillin
Antibiotics are prescribed for the patients.
Arms:
group 1, group 2
Analgesic
Analgesics are prescribed for the patients.
Arms:
control group, group 1, group 2, group 3, group 4
Antibiotic
Patients with penicillin allergy
Arms:
group 3, group 4
Size
75
Primary endpoint
visual analogue scale (VAS)
day 1
visual analogue scale (VAS)
day 2
visual analogue scale (VAS)
day 3
visual analogue scale (VAS)
day 7
visual analogue scale (VAS)
day 15
Trismus
day 1
Trismus
day 2
Trismus
day 3
Trismus
day 7
Trismus
day 15
swelling
day 1
swelling
day 2
swelling
day 3
swelling
day 7
swelling
day 15
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2024-03-22

1 organization

4 products

1 indication

Organization
Ceren Melahat Donmezer
Product
Platelet Rich Fibrin
Indication
Impacted Wisdom Tooth
Product
Penicillin
Product
Analgesic
Product
Antibiotic