Comparison The Postoperative Effects of Local and Systemic Antibiotics Applied With Platelets Rich Fibrin

Sponsor

Ceren Melahat Donmezer (Other)

Overall Status

Completed

CT.gov ID

NCT04989127

Collaborator

(none)

Enrollment

Location

23.2

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Impacted Wisdom Tooth	Diagnostic Test: Diagnosis Procedure: traditional osteotomies Biological: Platelet Rich Fibrin Drug: Antibiotics, Penicillin Drug: Analgesic Drug: Antibiotic

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 17, 2019

Actual Primary Completion Date :

Feb 20, 2021

Actual Study Completion Date :

Feb 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
group 1 platelet-rich fibrin placed into the socket of the extracted tooth.+ Augmentin 1 gr tablet prescribed 3 times a day	Diagnostic Test: Diagnosis 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. Drug: Analgesic Analgesics are prescribed for the patients.
group 2 platelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth.	Diagnostic Test: Diagnosis 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. Drug: Analgesic Analgesics are prescribed for the patients.
group 3 platelet-rich fibrin placed into the socket of extracted tooth + Clin 150 mg capsule prescribed 4 times a day	Diagnostic Test: Diagnosis 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: Analgesic Analgesics are prescribed for the patients. Drug: Antibiotic Patients with penicillin allergy
group 4 platelet-rich fibrin + 0.5 ml Clin 600 mg/4 ml IM/IV, 0.5 ml placed into the socket of the extracted tooth.	Diagnostic Test: Diagnosis 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: Analgesic Analgesics are prescribed for the patients. Drug: Antibiotic Patients with penicillin allergy
control group platelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed.	Diagnostic Test: Diagnosis 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: Analgesic Analgesics are prescribed for the patients.

Outcome Measures

Primary Outcome Measures

visual analogue scale (VAS) [day 1]
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS) [day 2]
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS) [day 3]
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS) [day 7]
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
visual analogue scale (VAS) [day 15]
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Trismus [day 1]
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus [day 2]
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus [day 3]
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus [day 7]
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Trismus [day 15]
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
swelling [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 [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 [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 [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.
swelling [day 15]
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.

Other Outcome Measures

the number of analgesic tablets [day 1,2,3,7 and 15]
Check the patients analgesic number of days 1,2,3,7 and 15.
the number of analgesic tablets [day 2]
Check the patients analgesic number of days 1,2,3,7 and 15.
the number of analgesic tablets [day 3]
Check the patients analgesic number of days 1,2,3,7 and 15.
the number of analgesic tablets [day 7]
Check the patients analgesic number of days 1,2,3,7 and 15.
the number of analgesic tablets [day 15]
Check the patients analgesic number of days 1,2,3,7 and 15.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.