Clinical trial NCT05678296: Investigation of Effectiveness of Local Antibiotic With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo
Official title: Investigation of Effectiveness of Local Antibiotic Applications With Platelet Rich Fibrin on Third Molar Surgery Outcomes In Vivo and In Vitro
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Wisdom Tooth
Pain
Staphylococcus Aureus
Keywords: local antibiotic
comparison
platelets rich fibrin
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 60
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: The patients with no systemic diseases aged between 19-45

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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: swelling
timeFrame: Day 1
measure: swelling
timeFrame: Day 2
measure: swelling
timeFrame: Day 3
measure: swelling
timeFrame: Day 7
measure: swelling
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
Secondary outcomes:
Other outcomes:
measure: Amount of analgesic tablets
timeFrame: day 1,2,3,7 and 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: Donmezer CM, Bilginaylar K. Comparison of the Postoperative Effects of Local Antibiotic versus Systemic Antibiotic with the Use of Platelet-Rich Fibrin on Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Study. Biomed Res Int. 2021 Dec 2;2021:3040661. doi: 10.1155/2021/3040661. eCollection 2021.
citation: Caymaz MG, Uyanik LO. Comparison of the effect of advanced platelet-rich fibrin and leukocyte- and platelet-rich fibrin on outcomes after removal of impacted mandibular third molar: A randomized split-mouth study. Niger J Clin Pract. 2019 Apr;22(4):546-552. doi: 10.4103/njcp.njcp_473_18.
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: 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.