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

NCT ID: NCT04989127

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-17

Study Completion Date

2021-02-21

Brief Summary

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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.

Detailed Description

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Conditions

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Impacted Wisdom Tooth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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group 1

platelet-rich fibrin placed into the socket of the extracted tooth.+ Augmentin 1 gr tablet prescribed 3 times a day

Diagnosis

Intervention Type DIAGNOSTIC_TEST

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

traditional osteotomies

Intervention Type PROCEDURE

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

Platelet Rich Fibrin

Intervention Type BIOLOGICAL

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.

Antibiotics, Penicillin

Intervention Type DRUG

Antibiotics are prescribed for the patients.

Analgesic

Intervention Type DRUG

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.

Diagnosis

Intervention Type DIAGNOSTIC_TEST

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

traditional osteotomies

Intervention Type PROCEDURE

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

Platelet Rich Fibrin

Intervention Type BIOLOGICAL

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.

Antibiotics, Penicillin

Intervention Type DRUG

Antibiotics are prescribed for the patients.

Analgesic

Intervention Type DRUG

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

Diagnosis

Intervention Type DIAGNOSTIC_TEST

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

traditional osteotomies

Intervention Type PROCEDURE

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

Platelet Rich Fibrin

Intervention Type BIOLOGICAL

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.

Analgesic

Intervention Type DRUG

Analgesics are prescribed for the patients.

Antibiotic

Intervention Type DRUG

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.

Diagnosis

Intervention Type DIAGNOSTIC_TEST

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

traditional osteotomies

Intervention Type PROCEDURE

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

Platelet Rich Fibrin

Intervention Type BIOLOGICAL

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.

Analgesic

Intervention Type DRUG

Analgesics are prescribed for the patients.

Antibiotic

Intervention Type DRUG

Patients with penicillin allergy

control group

platelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed.

Diagnosis

Intervention Type DIAGNOSTIC_TEST

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

traditional osteotomies

Intervention Type PROCEDURE

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

Platelet Rich Fibrin

Intervention Type BIOLOGICAL

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.

Analgesic

Intervention Type DRUG

Analgesics are prescribed for the patients.

Interventions

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Diagnosis

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

Intervention Type DIAGNOSTIC_TEST

traditional osteotomies

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

Intervention Type PROCEDURE

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.

Intervention Type BIOLOGICAL

Antibiotics, Penicillin

Antibiotics are prescribed for the patients.

Intervention Type DRUG

Analgesic

Analgesics are prescribed for the patients.

Intervention Type DRUG

Antibiotic

Patients with penicillin allergy

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ceren Melahat Donmezer

OTHER

Sponsor Role lead

Responsible Party

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Ceren Melahat Donmezer

Phd student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ceren Melahat Dönmezer

Role: PRINCIPAL_INVESTIGATOR

Near East University

Locations

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Near east University

Nicosia, Lefkosa, Cyprus

Site Status

Countries

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Cyprus

References

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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.

Reference Type BACKGROUND
PMID: 30629300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22275950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25110703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26209242 (View on PubMed)

Other Identifiers

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YDU/2019/67-774

Identifier Type: -

Identifier Source: org_study_id

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