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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678296
• Other study ID #: 67-774-2019
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: April 23, 2022

Study information

• Verified date: January 2023
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 23, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no inflammation

Related Conditions & MeSH terms

• Pain
• Staphylococcus Aureus
• Tooth, Impacted

Intervention

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.

Locations

Country	Name	City	State
Cyprus	Near east University	Nicosia	Lefkosa

Sponsors (1)

Lead Sponsor	Collaborator
Ceren Melahat Donmezer

Country where clinical trial is conducted

Cyprus, 

References & Publications (4)

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):546-55 — View 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; — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amount of analgesic tablets	Check the patients analgesic number of days 1,2,3,7 and 15.	day 1,2,3,7 and 15
Primary	visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 1
Primary	visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 2
Primary	visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 3
Primary	visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 7
Primary	visual analogue scale (VAS)	It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	Day 15
Primary	swelling	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.	Day 1
Primary	swelling	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.	Day 2
Primary	swelling	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.	Day 3
Primary	swelling	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.	Day 7
Primary	swelling	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.	Day 15
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 1
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 2
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 3
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 7
Primary	Trismus	Trismus by measuring the distance between the mesial incisal corners of the upper and lower right incisors during maximum mouth opening.	Day 15