Back to resultsComparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar
Primary Purpose
Pain, Postoperative, Trismus, Swelling
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Advanced Platelet Rich Fibrin (A-PRF)
Leukocyte- and platelet-rich fibrin (L-PRF)
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring Leukocyte- and platelet rich fibrin, Advanced platelet rich fibrin, Impacted mandibular third molar surgery
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
Sites / Locations
- Near East University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Advanced Platelet Rich Fibrin (A-PRF)
Leukocyte- and platelet-rich fibrin (L-PRF)
Arm Description
A-PRF was applied into the tooth socket after mandibular third molar surgery.
L-PRF was applied into the tooth socket after mandibular third molar surgery.
Outcomes
Primary Outcome Measures
Pain Scores Evaluted
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Pain Scores Evaluted
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Pain Scores Evaluted
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Pain Scores Evaluted
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Secondary Outcome Measures
Number of Analgesics Taken by the Patients
Trismus
Trismus was assessed by measuring the distance between the mesioincisal corner of the maxillary and mandibular right incisors while mouth was fully opened
Swelling on the cheek
In order to record swelling, a modification of the tape measurement method
Full Information
NCT ID
NCT03672669
First Posted
September 11, 2018
Last Updated
September 13, 2018
Sponsor
Near East University, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT03672669
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
May 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Near East University, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Trismus, Swelling
Keywords
Leukocyte- and platelet rich fibrin, Advanced platelet rich fibrin, Impacted mandibular third molar surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
patients with bilateral impacted mandibular third molar which surgically operated at different times
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Platelet Rich Fibrin (A-PRF)
Arm Type
Active Comparator
Arm Description
A-PRF was applied into the tooth socket after mandibular third molar surgery.
Arm Title
Leukocyte- and platelet-rich fibrin (L-PRF)
Arm Type
Active Comparator
Arm Description
L-PRF was applied into the tooth socket after mandibular third molar surgery.
Intervention Type
Genetic
Intervention Name(s)
Advanced Platelet Rich Fibrin (A-PRF)
Intervention Description
blood samples collected in 10 ml of vacuumed plain glass tubes were centrifuged for 14 minutes at 1500 rpm without anticoagulant agents in order to obtain A-PRF
Intervention Type
Genetic
Intervention Name(s)
Leukocyte- and platelet-rich fibrin (L-PRF)
Intervention Description
blood samples collected in 10 ml of glass coated plastic tubes were centrifuged without anticoagulant agents for 10 minutes in order to obtain L-PRF
Primary Outcome Measure Information:
Title
Pain Scores Evaluted
Description
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Time Frame
1st day after the operation.
Title
Pain Scores Evaluted
Description
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Time Frame
2nd day after the operation.
Title
Pain Scores Evaluted
Description
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Time Frame
3rd day after the operation.
Title
Pain Scores Evaluted
Description
For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).
Time Frame
7th day after the operation.
Secondary Outcome Measure Information:
Title
Number of Analgesics Taken by the Patients
Time Frame
Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.
Title
Trismus
Description
Trismus was assessed by measuring the distance between the mesioincisal corner of the maxillary and mandibular right incisors while mouth was fully opened
Time Frame
Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.
Title
Swelling on the cheek
Description
In order to record swelling, a modification of the tape measurement method
Time Frame
Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet G Caymaz, DDS
Organizational Affiliation
Near East University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Near East University
City
Mersin
ZIP/Postal Code
99138
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar
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