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Completed

NCT Number: NCT04989127

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

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.

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Key information

Conditions

Impacted Wisdom Tooth

Sex eligibility

All sexes

Study type

Observational

Primary location

Near east University

Nicosia, Lefkosa, 99138, Cyprus

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • pericoronitis, no inflammation

Treatment and study plan

Diagnosis

Diagnostic Test

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

traditional osteotomies

Procedure

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

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.

Antibiotics, Penicillin

Drug

Antibiotics are prescribed for the patients.

Analgesic

Drug

Analgesics are prescribed for the patients.

Antibiotic

Drug

Patients with penicillin allergy

Primary outcomes

  1. visual analogue scale (VAS)

    Time frame: day 1

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

  2. visual analogue scale (VAS)

    Time frame: day 2

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

  3. visual analogue scale (VAS)

    Time frame: day 3

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

  4. visual analogue scale (VAS)

    Time frame: day 7

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

  5. visual analogue scale (VAS)

    Time frame: day 15

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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Other outcomes

  1. the number 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.

  2. the number of analgesic tablets

    Time frame: day 2

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

  3. the number of analgesic tablets

    Time frame: day 3

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

  4. the number of analgesic tablets

    Time frame: day 7

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

  5. the number of analgesic tablets

    Time frame: day 15

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

Sponsors and collaborators

Lead sponsor

Ceren Melahat Donmezer

Other

Registry information

Official study title

Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2021
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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