Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery
| Registry | NCT04989127 |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 75 (Actual) |
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| Sponsor | Ceren Melahat Donmezer (Other) |
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| Conditions | Impacted Wisdom Tooth |
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| Interventions | Diagnosis, traditional osteotomies, Platelet Rich Fibrin, Antibiotics, Penicillin, Analgesic, Antibiotic (Diagnostic test, procedure, biological, drug) |
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| Dates | start 2019-03-17, primary completion 2021-02-20, completion 2021-02-21, first posted 2021-08-04, last updated 2024-03-22 |
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| Locations | 1 site in Cyprus |
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Related Papers Related Patents Related Grants Related Experts
All trials for Impacted Wisdom Tooth All trials of Diagnosis All trials of traditional osteotomies
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| group 1 | | Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic | platelet-rich fibrin placed into the socket of the extracted tooth.+ Augmentin 1 gr tablet prescribed 3 times a day |
| group 2 | | Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Antibiotics, Penicillin; Drug: Analgesic | platelet-rich fibrin + 0.5 ml amoklavin I.V. 1.2 gr placed into the socket of the extracted tooth. |
| group 3 | | Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic; Drug: Antibiotic | platelet-rich fibrin placed into the socket of extracted tooth + Clin 150 mg capsule prescribed 4 times a day |
| group 4 | | Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic; Drug: Antibiotic | platelet-rich fibrin + 0.5 ml Clin 600 mg/4 ml IM/IV, 0.5 ml placed into the socket of the extracted tooth. |
| control group | | Diagnostic Test: Diagnosis; Procedure: traditional osteotomies; Biological: Platelet Rich Fibrin; Drug: Analgesic | platelet-rich fibrin placed into the socket of extracted tooth and no antibiotic is prescribed. |
- 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
+Outcome measures
Primary outcomes
- visual analogue scale (VAS) [day 1]: It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
- visual analogue scale (VAS) [day 2]: It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
- visual analogue scale (VAS) [day 3]: It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
- visual analogue scale (VAS) [day 7]: It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
- visual analogue scale (VAS) [day 15]: It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
- Trismus [day 1]: Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
- Trismus [day 2]: Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
- Trismus [day 3]: Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
- Trismus [day 7]: Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
- Trismus [day 15]: Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.
- 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.
- 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.
- 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.
- 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.
- 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.
Other outcomes
- the number of analgesic tablets [day 1,2,3,7 and 15]: Check the patients analgesic number of days 1,2,3,7 and 15.
- the number of analgesic tablets [day 2]: Check the patients analgesic number of days 1,2,3,7 and 15.
- the number of analgesic tablets [day 3]: Check the patients analgesic number of days 1,2,3,7 and 15.
- the number of analgesic tablets [day 7]: Check the patients analgesic number of days 1,2,3,7 and 15.
- the number of analgesic tablets [day 15]: Check the patients analgesic number of days 1,2,3,7 and 15.
+Eligibility
Sex: All, accepts healthy volunteers
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
+Locations (1)
| Facility | City | Country | Status |
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| Near east University | Nicosia, Lefkosa | Cyprus | |
+Publications
- 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
- 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
- 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
- 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
+Investigators
- Ceren Melahat Dönmezer, Principal investigator, Near East University