Trial Outcomes & Findings for Investigation of the Effects of H-PRF on the Period After Impacted Third Molar Tooth Extraction (NCT NCT06244797)
NCT ID: NCT06244797
Last Updated: 2026-01-23
Results Overview
Swelling was evaluated by measuring three linear facial distances: LC-M (lateral canthus to mandibular angle), T-CL (tragus to labial commissure), and T-P (tragus to soft tissue pogonion). The sum of these distances (in mm) was calculated for each participant preoperatively and on postoperative Days 2 and 7. Mean values are reported. Higher values indicate greater swelling. Time Frame: Postoperative Day 2 and Day 7 Unit of Measure: Millimeters (mm) Measure Type: Mean Measure of Dispersion/Precision: Standard Deviation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Postoperative day 2 and day 7
Results posted on
2026-01-23
Participant Flow
No washout or run-in period was used. After enrollment, no participants were excluded or withdrew prior to randomization; all enrolled participants were assigned to an arm.
Participant milestones
| Measure |
CONTROL GROUP
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of the Effects of H-PRF on the Period After Impacted Third Molar Tooth Extraction
Baseline characteristics by cohort
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=270 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=9 Participants
|
75 Participants
n=220 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
|
Age, Continuous
|
23.88 years
STANDARD_DEVIATION 5.01 • n=270 Participants
|
24.28 years
STANDARD_DEVIATION 5.88 • n=4 Participants
|
24.24 years
STANDARD_DEVIATION 4.64 • n=9 Participants
|
24.13 years
STANDARD_DEVIATION 5.17 • n=220 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=270 Participants
|
19 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
49 Participants
n=220 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=9 Participants
|
26 Participants
n=220 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=270 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=9 Participants
|
75 Participants
n=220 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
|
Region of Enrollment
Turkey
|
25 Participants
n=270 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=9 Participants
|
75 Participants
n=220 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 2 and day 7Swelling was evaluated by measuring three linear facial distances: LC-M (lateral canthus to mandibular angle), T-CL (tragus to labial commissure), and T-P (tragus to soft tissue pogonion). The sum of these distances (in mm) was calculated for each participant preoperatively and on postoperative Days 2 and 7. Mean values are reported. Higher values indicate greater swelling. Time Frame: Postoperative Day 2 and Day 7 Unit of Measure: Millimeters (mm) Measure Type: Mean Measure of Dispersion/Precision: Standard Deviation
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Postoperative Facial Swelling (Sum of 3 Linear Distances, mm)
Day 2
|
122.08 Millimeters (mm)
Standard Deviation 6.02
|
118.55 Millimeters (mm)
Standard Deviation 7.22
|
116.90 Millimeters (mm)
Standard Deviation 6.57
|
|
Postoperative Facial Swelling (Sum of 3 Linear Distances, mm)
Day 7
|
119.68 Millimeters (mm)
Standard Deviation 5.97
|
115.69 Millimeters (mm)
Standard Deviation 6.68
|
114.23 Millimeters (mm)
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: postoperative day 2 and day 7Population: All randomized participants who completed trismus assessments at the specified time points
Trismus was assessed by measuring the maximum interincisal distance (mouth opening) with a calibrated ruler. Measurements were recorded on postoperative Days 2 and 7. Lower values indicate more restricted mouth opening.
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Maximum Interincisal Distance (Mouth Opening, mm)
Day 7
|
38.96 Millimeters (mm)
Standard Deviation 5.89
|
39.48 Millimeters (mm)
Standard Deviation 6.18
|
38.92 Millimeters (mm)
Standard Deviation 6.10
|
|
Maximum Interincisal Distance (Mouth Opening, mm)
Day 2
|
28.56 Millimeters (mm)
Standard Deviation 8.94
|
29.48 Millimeters (mm)
Standard Deviation 5.69
|
31.20 Millimeters (mm)
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Postoperative Day 2 and Day 7Population: All randomized participants who completed the healing assessment at each time point were analyzed. In the L-PRF arm, one participant's postoperative Day 2 and Day 7 Landry index assessments were not recorded due to a documentation error; therefore, 24 participants were analyzed for this outcome in that arm. No imputation was performed. The category 'Very poor' (score = 1) was part of the Landry index but was not observed in any participant on both days.
Healing was assessed using the Landry index, a 5-point ordinal scale (1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = excellent). Assessments were performed on postoperative Days 2 and 7 by a blinded examiner. Higher scores indicate better healing.
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=24 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 2: Poor
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 2:Fair
|
14 Participants
|
13 Participants
|
9 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 2: Good
|
3 Participants
|
8 Participants
|
9 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 2: Excellent
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 7: Poor
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 7: Fair
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day7 : Good
|
15 Participants
|
10 Participants
|
10 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 7:Excellent
|
4 Participants
|
13 Participants
|
14 Participants
|
|
Soft Tissue Healing (Landry Index, 5-point Scale)
day 2 and 7:Very poor
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours after surgery and postoperative Days 1 through 7Population: All randomized participants who completed the pain assessment at each time point were analyzed.
The patient's pain assessment will be made with a visual analog scale (VAS). According to this evaluation, a line of a certain length is divided into 10 equal parts. 0 = no pain, 5 = moderate pain, and 10 = unbearable pain. This statement will be reported to the patient verbally, and the patient will be asked to mark the severity of his pain on this note. The patient will be asked to mark the severity of pain on the VAS scale at the 6th hour, 24th hour, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, and 7th day, and how often anti-inflammatory drugs should be used. Higher scores will be assessed as a worse outcome.
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Postoperative Pain (Visual Analog Scale, 0-10)
6 hours
|
6 Score on a scale (0-10)
Interval 1.0 to 10.0
|
5 Score on a scale (0-10)
Interval 0.0 to 10.0
|
6 Score on a scale (0-10)
Interval 0.0 to 10.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 1
|
5 Score on a scale (0-10)
Interval 1.0 to 10.0
|
4 Score on a scale (0-10)
Interval 0.0 to 8.0
|
4 Score on a scale (0-10)
Interval 0.0 to 9.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 2
|
4 Score on a scale (0-10)
Interval 0.0 to 10.0
|
3 Score on a scale (0-10)
Interval 0.0 to 7.0
|
3 Score on a scale (0-10)
Interval 0.0 to 9.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 3
|
3 Score on a scale (0-10)
Interval 0.0 to 8.0
|
1 Score on a scale (0-10)
Interval 0.0 to 5.0
|
1 Score on a scale (0-10)
Interval 0.0 to 8.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 4
|
2 Score on a scale (0-10)
Interval 0.0 to 8.0
|
1 Score on a scale (0-10)
Interval 0.0 to 5.0
|
1 Score on a scale (0-10)
Interval 0.0 to 8.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 5
|
1 Score on a scale (0-10)
Interval 0.0 to 6.0
|
0 Score on a scale (0-10)
Interval 0.0 to 3.0
|
0 Score on a scale (0-10)
Interval 0.0 to 6.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 6
|
1 Score on a scale (0-10)
Interval 0.0 to 9.0
|
0 Score on a scale (0-10)
Interval 0.0 to 4.0
|
0 Score on a scale (0-10)
Interval 0.0 to 7.0
|
|
Postoperative Pain (Visual Analog Scale, 0-10)
Day 7
|
0 Score on a scale (0-10)
Interval 0.0 to 5.0
|
0 Score on a scale (0-10)
Interval 0.0 to 3.0
|
0 Score on a scale (0-10)
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Postoperative Day 4Population: Total QoL was analyzed on Day 4 only; Day 7 had subscales only.
QoL was assessed using the Majid questionnaire (each item 0-3; total range 0-42). Higher scores indicate worse QoL. A total score was calculated only on postoperative Day 4; on Day 7 only subscale scores were analyzed (no total score).
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
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|---|---|---|---|
|
Oral Health-Related Quality of Life (Majid Questionnaire, Total Score 0-42)
|
11.56 Score (0-42)
Standard Deviation 6.92
|
10.67 Score (0-42)
Standard Deviation 5.11
|
12.92 Score (0-42)
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: Postoperative Day 7Population: No total score was calculated at Day 7.
On postoperative Day 7, Majid questionnaire subscales were recorded as days with symptoms in the past week (possible range 0-7 days for each subscale). Higher values indicate worse QoL. We report median (full range) per arm. No total score was calculated at Day 7.
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Oral Health-Related Quality of Life (Majid Questionnaire Subscales; Days With Symptoms, 0-7)
Day 7-Speaking
|
1 Days (0-7)
Interval 0.0 to 7.0
|
1.5 Days (0-7)
Interval 0.0 to 5.0
|
2 Days (0-7)
Interval 0.0 to 4.0
|
|
Oral Health-Related Quality of Life (Majid Questionnaire Subscales; Days With Symptoms, 0-7)
Day 7-Social Isolation
|
1 Days (0-7)
Interval 0.0 to 3.0
|
2 Days (0-7)
Interval 0.0 to 7.0
|
1 Days (0-7)
Interval 0.0 to 5.0
|
|
Oral Health-Related Quality of Life (Majid Questionnaire Subscales; Days With Symptoms, 0-7)
Day 7-Sleeping
|
1 Days (0-7)
Interval 0.0 to 5.0
|
1 Days (0-7)
Interval 0.0 to 5.0
|
1 Days (0-7)
Interval 0.0 to 4.0
|
|
Oral Health-Related Quality of Life (Majid Questionnaire Subscales; Days With Symptoms, 0-7)
Day 7-Physical appearance
|
2 Days (0-7)
Interval 0.0 to 7.0
|
1.5 Days (0-7)
Interval 0.0 to 5.0
|
3 Days (0-7)
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Postoperative Day 7Population: On postoperative Day 7, Eating \& Drinking difficulty days were recorded (possible range 0-7 days; higher = worse). We report mean ± SD per arm.
On postoperative Day 7, Eating \& Drinking difficulty days were recorded (possible range 0-7 days; higher = worse). We report mean ± SD per arm.
Outcome measures
| Measure |
CONTROL GROUP
n=25 Participants
Patient group in which no material is placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
L-PRF (Leukocyte-platelet Rich Fibrin):
n=25 Participants
The patient group in which L-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815P centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
H-PRF (Horizontal-platelet Rich Fibrin)
n=25 Participants
The patient group in which H-PRF will be placed in the extraction socket after impacted tooth extraction. There will be 25 patients in this group. Device information to be used: Electromag M815A2 centrifuge device.
L-PRF and H-PRF: Blood (10 ml) will be taken from the patient with the help of an intraket in the arm or hand of appropriate size and size. Then, the blood sample taken will be placed in the PRF device for centrifugation and the sample will be centrifuged. According to the type of PRF, the centrifuge settings will be changed.
Impacted Tooth Removal: All patients will be operated on by the same surgeon using the same procedure in order to ensure standardization. Following the administration of 2% articaine with 1:200,000 adrenalin for the inferior alveolar and buccal nerve blocks, a full-thickness mucoperiosteal flap will be raised, and the tooth will be extracted. Following the extraction of the tooth, sterile saline irrigation will be used in the socket, and bleeding control measures will be taken.
|
|---|---|---|---|
|
Oral Health-Related Quality of Life (Majid - Eating & Drinking; Days With Symptoms, 0-7)
|
2.96 Days (0-7)
Standard Deviation 1.49
|
3.17 Days (0-7)
Standard Deviation 2.04
|
3.6 Days (0-7)
Standard Deviation 1.55
|
Adverse Events
CONTROL GROUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
L-PRF (Leukocyte-platelet Rich Fibrin):
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
H-PRF (Horizontal-platelet Rich Fibrin)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place