Investigation of Effectiveness of Local Antibiotic With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo

NCT ID: NCT05678296

Last Updated: 2023-01-11

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2022-04-23

Brief Summary

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The aim of this study was investigate the effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 3 randomly separated groups. For the first and second group, Platelets Rich Fibrin+ local antibiotics were applied into the tooth socket. For the first group, amoxicillin was applied and for the second group, clindamycin was applied. 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 Pain Staphylococcus Aureus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Analgesic

Intervention Type DRUG

Analgesics are prescribed for the patients for all groups.

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.

group 1

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.

Analgesic

Intervention Type DRUG

Analgesics are prescribed for the patients for all groups.

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.

Antibiotic

Intervention Type DRUG

no systemic antibiotics are prescribed for the patients for all groups.

group 2

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.

Analgesic

Intervention Type DRUG

Analgesics are prescribed for the patients for all groups.

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.

Antibiotic

Intervention Type DRUG

no systemic antibiotics are prescribed for the patients for all groups.

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

Analgesic

Analgesics are prescribed for the patients for all groups.

Intervention Type DRUG

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

Antibiotic

no systemic antibiotics are prescribed for the patients for all groups.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patient with no systemic diseases, no current infection, no smoke, no pregnancy

Exclusion Criteria

* 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

Principal Investigator, Oral and Maxillofacial Surgeon

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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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.

Reference Type RESULT
PMID: 34901267 (View on PubMed)

Caymaz MG, Uyanik LO. Comparison of the effect of advanced platelet-rich fibrin and leukocyte- and platelet-rich fibrin on outcomes after removal of impacted mandibular third molar: A randomized split-mouth study. Niger J Clin Pract. 2019 Apr;22(4):546-552. doi: 10.4103/njcp.njcp_473_18.

Reference Type RESULT
PMID: 30975961 (View on PubMed)

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 RESULT
PMID: 30629300 (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 RESULT
PMID: 26209242 (View on PubMed)

Other Identifiers

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67-774-2019

Identifier Type: -

Identifier Source: org_study_id

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