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

NCT05678296 | Completed

• 1 other identifier: 67-774-2019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Wisdom Tooth; Pain; Staphylococcus Aureus

Keywords

local antibiotic; comparison; platelets rich fibrin

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

• 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

• 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

Other Outcomes (1)

• Amount of analgesic tablets

  day 1,2,3,7 and 15

Study Arms (3)

control group

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

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

group 1

platelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth.

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

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.

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

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

Analgesic DRUG

Analgesics are prescribed for the patients for all groups.

control group; group 1; group 2

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

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

Antibiotic DRUG

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

group 1; group 2

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

The patients with no systemic diseases aged between 19-45

You may qualify if:

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

You may not qualify if:

• no inflammation

Sponsors & Collaborators

• Ceren Melahat Donmezer: lead

Study Sites (1)

Near east University

Nicosia, Lefkosa, 99138, Cyprus

Location

Related Publications (4)

• 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.

  PMID: 34901267 RESULT

• 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.

  PMID: 30975961 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pain; Staphylococcal Infections

Interventions

Diagnosis; Analgesics; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

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: Principal Investigator, Oral and Maxillofacial Surgeon

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 10, 2023
• Study Start: April 20, 2020
• Primary Completion: February 17, 2022
• Study Completion: April 23, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)