Clinical trial NCT03672669: Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar
Official title: 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 Randomised Split-mouth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Trismus
Swelling
Keywords: Leukocyte- and platelet rich fibrin
Advanced platelet rich fibrin
Impacted mandibular third molar surgery
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: patients with bilateral impacted mandibular third molar which surgically operated at different times
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it was aimed to investigating and comparing the postoperative effects of leukocyte- and platelet-rich fibrin (L-PRF) and advanced platelet-rich fibrin (A-PRF) in terms of pain, swelling on the cheek, and trismus after mandibular third molar surgery. The study included a total of 27 patients with bilateral impacted mandibular third molar which surgically operated at different times. Patients were evaluated in two randomly separated groups. For the first group; A-PRF and for the second group; L-PRF was applied into the tooth socket. The outcomes variables were; pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed on the basis of; 1st, 2nd, 3rd and 7th days following the operation.


Eligibility criteria: Inclusion Criteria:

* age≥18
* the presence of bilaterally symmetrically impacted mandibular third molar, which requires an extraction for prophylactic reasons
* absence of systemic diseases
* absence of chronic opioid taken;
* not being pregnant
* not smoking and no alcohol usage
* the absence of allergy to penicillin or any other drugs used during standardized postoperative therapy.

Exclusion Criteria:

* tooth needed to be sectioning during the operation
* operation time exceeding 30 minutes
* the cases with severe periodontal disease or acute pericoronitis,
* the cases using antibiotics for an existing infection
* the cases not capable of following postoperative instructions

Primary outcomes:
measure: Pain Scores Evaluted
timeFrame: 1st day after the operation.
measure: Pain Scores Evaluted
timeFrame: 2nd day after the operation.
measure: Pain Scores Evaluted
timeFrame: 3rd day after the operation.
measure: Pain Scores Evaluted
timeFrame: 7th day after the operation.
Secondary outcomes:
measure: Number of Analgesics Taken by the Patients
timeFrame: Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.
measure: Trismus
timeFrame: Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.
measure: Swelling on the cheek
timeFrame: Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Near East University
Study officials:
affiliation: Near East University
name: Mehmet G Caymaz, DDS
role: PRINCIPAL_INVESTIGATOR
References: