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

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

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.

Study Overview

• Status: Completed
• Conditions: Impacted Wisdom Tooth
• Intervention / Treatment: Diagnostic test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic; Drug: Antibiotic

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Cyprus
  • Lefkosa
    • Nicosia, Lefkosa, Cyprus, 99138
      • Near East University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	day 15
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
Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	day 15
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
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 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of analgesic tablets	Check the patients analgesic number of days 1,2,3,7 and 15.	day 1,2,3,7 and 15
the number of analgesic tablets	Check the patients analgesic number of days 1,2,3,7 and 15.	day 2
the number of analgesic tablets	Check the patients analgesic number of days 1,2,3,7 and 15.	day 3
the number of analgesic tablets	Check the patients analgesic number of days 1,2,3,7 and 15.	day 7
the number of analgesic tablets	Check the patients analgesic number of days 1,2,3,7 and 15.	day 15

Collaborators and Investigators

• Sponsor: Ceren Melahat Donmezer
• Investigators: Principal Investigator: Ceren Melahat Dönmezer, Near East University

Publications and helpful links

General Publications

• Polak D, Clemer-Shamai N, Shapira L. Incorporating antibiotics into platelet-rich fibrin: A novel antibiotics slow-release biological device. J Clin Periodontol. 2019 Feb;46(2):241-247. doi: 10.1111/jcpe.13063.
• Osunde OD, Adebola RA, Omeje UK. Management of inflammatory complications in third molar surgery: a review of the literature. Afr Health Sci. 2011 Sep;11(3):530-7.
• Kreutzer K, Storck K, Weitz J. Current evidence regarding prophylactic antibiotics in head and neck and maxillofacial surgery. Biomed Res Int. 2014;2014:879437. doi: 10.1155/2014/879437. Epub 2014 Jul 8.
• Uyanik LO, Bilginaylar K, Etikan I. Effects of platelet-rich fibrin and piezosurgery on impacted mandibular third molar surgery outcomes. Head Face Med. 2015 Jul 26;11:25. doi: 10.1186/s13005-015-0081-x.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2019
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): February 21, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: comparison; platelets rich fibrin; systemic antibiotic; local antibiotic
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Sensory System Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular; Analgesics; Penicillins
• Other Study ID Numbers: YDU/2019/67-774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No