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

Sponsor
Ceren Melahat Donmezer (Other)
Overall Status
Completed
CT.gov ID
NCT05678296
Collaborator
(none)
60
1
24.1
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Investigation of Effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Feb 17, 2022
Actual Study Completion Date :
Apr 23, 2022

Arms and Interventions

Arm 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.

Drug: Analgesic
Analgesics are prescribed for the patients for all groups.

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.

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.

Drug: Analgesic
Analgesics are prescribed for the patients for all groups.

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: 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.

Drug: Analgesic
Analgesics are prescribed for the patients for all groups.

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

Outcome Measures

Primary Outcome Measures

  1. visual analogue scale (VAS) [Day 1]

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

  2. visual analogue scale (VAS) [Day 2]

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

  3. visual analogue scale (VAS) [Day 3]

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

  4. visual analogue scale (VAS) [Day 7]

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

  5. visual analogue scale (VAS) [Day 15]

    It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

  6. swelling [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.

  7. swelling [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.

  8. swelling [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.

  9. swelling [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.

  10. swelling [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.

  11. Trismus [Day 1]

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

  12. Trismus [Day 2]

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

  13. Trismus [Day 3]

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

  14. Trismus [Day 7]

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

  15. Trismus [Day 15]

    Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.

Other Outcome Measures

  1. Amount of analgesic tablets [day 1,2,3,7 and 15]

    Check the patients analgesic number of days 1,2,3,7 and 15.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • patient with no systemic diseases, no current infection, no smoke, no pregnancy
Exclusion Criteria:
  • no inflammation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Near east University Nicosia Lefkosa Cyprus 99138

Sponsors and Collaborators

  • Ceren Melahat Donmezer

Investigators

  • Principal Investigator: Ceren Melahat Dönmezer, Near East University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ceren Melahat Donmezer, Principal Investigator, Oral and Maxillofacial Surgeon, Near East University, Turkey
ClinicalTrials.gov Identifier:
NCT05678296
Other Study ID Numbers:
  • 67-774-2019
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ceren Melahat Donmezer, Principal Investigator, Oral and Maxillofacial Surgeon, Near East University, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023