Clinical trial NCT04989127: Comparison The Postoperative Effects of Local and Systemic Antibiotics Applied With Platelets Rich Fibrin
Official title: Comparison The Postoperative Effects Of Local Antibiotic Versus Systemic Antibiotic With The Use Of Platelet Rich Fibrin On The Mandibular Third Molar Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Wisdom Tooth
Keywords: platelets rich fibrin
systemic antibiotic
local antibiotic
comparison
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community aged between 18-40 without any important systemic disease.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: day 1
measure: visual analogue scale (VAS)
timeFrame: day 2
measure: visual analogue scale (VAS)
timeFrame: day 3
measure: visual analogue scale (VAS)
timeFrame: day 7
measure: visual analogue scale (VAS)
timeFrame: day 15
measure: Trismus
timeFrame: day 1
measure: Trismus
timeFrame: day 2
measure: Trismus
timeFrame: day 3
measure: Trismus
timeFrame: day 7
measure: Trismus
timeFrame: day 15
measure: swelling
timeFrame: day 1
measure: swelling
timeFrame: day 2
measure: swelling
timeFrame: day 3
measure: swelling
timeFrame: day 7
measure: swelling
timeFrame: day 15
Secondary outcomes:
Other outcomes:
measure: the number of analgesic tablets
timeFrame: day 1,2,3,7 and 15
measure: the number of analgesic tablets
timeFrame: day 2
measure: the number of analgesic tablets
timeFrame: day 3
measure: the number of analgesic tablets
timeFrame: day 7
measure: the number of analgesic tablets
timeFrame: day 15
Locations:
city: Nicosia
country: Cyprus
facility: Near east University
state: Lefkosa
Study officials:
affiliation: Near East University
name: Ceren Melahat Dönmezer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.