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

NCT04989127 | Completed

• 1 other identifier: YDU/2019/67-774
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Wisdom Tooth

Keywords

platelets rich fibrin; systemic antibiotic; local antibiotic; comparison

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• the number of analgesic tablets

  day 1,2,3,7 and 15

• the number of analgesic tablets

  day 2

• the number of analgesic tablets

  day 3

Study Arms (5)

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; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic

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; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic

group 3

platelet-rich fibrin placed into the socket of extracted tooth + Clin 150 mg capsule prescribed 4 times a day

Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic; Drug: Antibiotic

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; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic; Drug: Antibiotic

control group

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

Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic

Interventions

Diagnosis DIAGNOSTIC_TEST

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

control group; group 1; group 2; group 3; group 4

traditional osteotomies PROCEDURE

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

control group; group 1; group 2; group 3; group 4

Platelet Rich Fibrin 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.

control group; group 1; group 2; group 3; group 4

Antibiotics, Penicillin DRUG

Antibiotics are prescribed for the patients.

group 1; group 2

Analgesic DRUG

Analgesics are prescribed for the patients.

control group; group 1; group 2; group 3; group 4

Antibiotic DRUG

Patients with penicillin allergy

group 3; group 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• pericoronitis, no inflammation

Sponsors & Collaborators

• Ceren Melahat Donmezer: lead

Study Sites (1)

Near east University

Nicosia, Lefkosa, 99138, Cyprus

Location

Related Publications (4)

• 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.

  PMID: 30629300 BACKGROUND

• 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.

  PMID: 22275950 BACKGROUND

• 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.

  PMID: 25110703 BACKGROUND

• 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.

  PMID: 26209242 BACKGROUND

MeSH Terms

Interventions

Diagnosis; Penicillins; Analgesics; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Anti-Infective Agents

Study Officials

• Ceren Melahat Dönmezer

  Near East University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd student

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 4, 2021
• Study Start: March 17, 2019
• Primary Completion: February 20, 2021
• Study Completion: February 21, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)