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

January 10, 2023 updated by: Ceren Melahat Donmezer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with no systemic diseases aged between 19-45

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no inflammation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 for all groups.
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
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 for all groups.
Drug: Antibiotic
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.
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 for all groups.
Drug: Antibiotic
no systemic antibiotics are prescribed for the patients for all groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale (VAS)
Time Frame: Day 1
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 1
visual analogue scale (VAS)
Time Frame: Day 2
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 2
visual analogue scale (VAS)
Time Frame: Day 3
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 3
visual analogue scale (VAS)
Time Frame: Day 7
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 7
visual analogue scale (VAS)
Time Frame: Day 15
It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Day 15
swelling
Time Frame: Day 1
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
Time Frame: Day 2
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
Time Frame: Day 3
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
Time Frame: Day 7
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
Time Frame: Day 15
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
Time Frame: Day 1
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 1
Trismus
Time Frame: Day 2
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 2
Trismus
Time Frame: Day 3
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 3
Trismus
Time Frame: Day 7
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 7
Trismus
Time Frame: Day 15
Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
Day 15

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceren Melahat Donmezer

Investigators

  • Principal Investigator: Ceren Melahat Dönmezer, Near East University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

April 23, 2022

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67-774-2019

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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