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The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin) (A-PRF+)

Primary Purpose

PRF

Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
A-PRF+
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for PRF focused on measuring Impacted mandibular third molar, tooth extraction, A-PRF+, pain, trismus, swelling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Older than 18 of age Healthy patients (ASA PS index ≤ 2) The impacted mandibular third molar (IMTM) had to be in the "deep molars" ≥ 2 (according to Montero classification) Absence of acute inflammation and/or infection in the IMTM areas No history of NSAID usage four weeks before surgery Exclusion Criteria: Those with systemic conditions or pharmacologic treatments that alter oral microbiota or immunologic response Pregnant or breastfeeding women Those with the presence of any neoplastic lesion (benign or malignant), clinically or radiologically, at the extraction site or close to the IMTM Those with the presence of any radiolucent lesion larger than 1cm at the IMTM Those absent of the adjacent teeth Lack of compliance

Sites / Locations

  • National Hospital of Odonto-Stomatology, Ho Chi Minh City

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Participants had their impacted mandibular third molar (IMTM) extracted according to the standard procedure.

20ml of venous blood was collected from each participant in this group into two glass tubes (10ml, A-PRF by Choukroun) and centrifuge to create A-PRF+ using Dou Quattro Choukroun PRF machine with a speed of 1300 rpm in 8 minutes, centrifugal force at the bottom of the tube was RCFmax 208g (RCFmin=113g, RCFav=164g, RCFclot=145g). After the standard extraction procedure, place two A-PRF+ clots in the IMTM socket before suturing.

Outcomes

Primary Outcome Measures

VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
VAS index indicating pain value 4 hours immediately after the lips stopped feeling numb
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
VAS index indicating pain value 6 hours immediately after the lips stopped feeling numb
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
VAS index indicating pain value 1 day after surgery
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
VAS index indicating pain value 3 days after surgery
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
VAS index indicating pain value 7 days after surgery
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Maximum mouth opening at baseline
The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus.
Change in maximum mouth opening between baseline and 3 days after surgery
The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus
Change in maximum mouth opening between baseline and 7 days after surgery
The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus
Mean Facial Landmark Length at baseline
Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.
Mean Facial Landmark Length 3 days after operation
Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.
Mean Facial Landmark Length 7 days after operation
Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2023
Last Updated
April 10, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT05824793
Brief Title
The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin)
Acronym
A-PRF+
Official Title
The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

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
Objectives: This study aims to evaluate the effects of A-PRF+ on postoperative pain, swelling, and trismus after surgical removal of impacted mandibular third molars. Method and Materials: A randomized controlled trial with a parallel design was performed on healthy patients with 76 impacted mandibular third molars with similar difficulty level, having needs and indications for extraction. All patients had the same standardized extraction protocol at the Department of Minor Oral Surgery of the National Hospital of Odonto - Stomatology in HCM City. In the study group, patients' blood was collected and centrifugated to produce A-PRF+, then placed in the wisdom tooth sockets after surgery. In the control group, the tooth sockets were curetted and sutured as in standard protocol. Pain value was assessed according to the VAS at 2, 4, and 6-hour time points after patients' lower lips stopped feeling numb, and on the 1st, 3rd, and 7th postoperative day; Swelling was evaluated based on the measurement between facial landmarks; Trismus was assessed based on the distance between incisal edges of upper central incisor and lower incisor during maximum mouth opening on the 3rd and 7th postoperative days. Data obtained were statistically analyzed.
Detailed Description
The study was a parallel randomized controlled trial on patients having impacted mandibular third molar (IMTM) extraction. This study was performed at the Department of Minor Oral Surgery in the National Hospital of Odonto - Stomatology in HCM City from October 2019 to April 2021. All patients who had IMTM extraction were examined by the dentists at the Department of Minor Oral Surgery. If IMTM were Montero≥2(7), patients would be referred to the research team. After reviewing the criteria for inclusion and exclusion, the investigators explained to all patients the information about the operation, healing time, and possible complications, and the investigators obtained their informed consent before surgery. Based on recent research with a power of 80% and α=5%, the investigators calculated the minimum sample size for comparing 2 mean values. The result is each group needs a minimum of 36 participants. The initial sample consisted of 85 in both groups intended to participate in this study at the Department of Minor Oral Surgery in the National Hospital of Odonto - Stomatology in HCM City from October 2019 to April 2021. One patient was excluded from this study because of the ASA PS Index>2. After randomization, one patient in the study group could not collect blood for centrifugation; seven patients were excluded due to lack of compliance (four in the control group, three in the study group). Finally, 76 samples remained in this study (Male 23, Female 53).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRF
Keywords
Impacted mandibular third molar, tooth extraction, A-PRF+, pain, trismus, swelling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Each patient enrolled in the research was encoded using a code from 001 to n, in blocks of 10 numbers, compared to the number on the sealed envelope with the random number pre-selected via the function RAND() on Microsoft Excel by the data collector. Number in the patient's envelope: odd number of group 1, even number of group 2. In case the patient has two IMTM that need to be extracted, meeting the inclusion and exclusion criteria of the study; after random: if the first time in the odd group, be operated on according to the standard procedure, the remaining opposite teeth would be surgically operated on using A-PRF+, the second time after the first surgery at least five weeks. And similarly, if randomly selecting the number is an even. Control group (group 1 = odd number): no use of A-PRF+ after tooth extraction. Study group (group 2 = even number): use A-PRF+ after tooth extraction.
Masking
Outcomes Assessor
Masking Description
Each participant was assigned a unique identifier number which does not inform the group they are in. The outcome assessor was not aware of which group the participants were allocated in.
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants had their impacted mandibular third molar (IMTM) extracted according to the standard procedure.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
20ml of venous blood was collected from each participant in this group into two glass tubes (10ml, A-PRF by Choukroun) and centrifuge to create A-PRF+ using Dou Quattro Choukroun PRF machine with a speed of 1300 rpm in 8 minutes, centrifugal force at the bottom of the tube was RCFmax 208g (RCFmin=113g, RCFav=164g, RCFclot=145g). After the standard extraction procedure, place two A-PRF+ clots in the IMTM socket before suturing.
Intervention Type
Combination Product
Intervention Name(s)
A-PRF+
Intervention Description
A-PRF+ contributes to accelerating the healing process, more rapid revascularization, and reducing the risk of inflammation at the graft site. It leads to a decrease in the severity of postoperative complications. Many authors have mentioned platelet concentrates as an effective adjunction that improves the healing of hard and soft tissue and decreases pain, swelling, and trismus. However, there are still some controversial results in the literature. Recently, it has been demonstrated that the production of PRF with lower centrifugal force and lower centrifugal time has more potential to release several growth factors and facilitate more favorable healing at the site of the application when compared to standard PRF. Promoting the healing process after tooth extraction using A-PRF+ aims to manage patient discomfort as well as postoperation complications.
Primary Outcome Measure Information:
Title
VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb
Description
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Time Frame
2 hours immediately after the lips stopped feeling numb
Title
VAS index indicating pain value 4 hours immediately after the lips stopped feeling numb
Description
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Time Frame
4 hours immediately after the lips stopped feeling numb
Title
VAS index indicating pain value 6 hours immediately after the lips stopped feeling numb
Description
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Time Frame
6 hours immediately after the lips stopped feeling numb
Title
VAS index indicating pain value 1 day after surgery
Description
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Time Frame
1 day after surgery
Title
VAS index indicating pain value 3 days after surgery
Description
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Time Frame
3 days after surgery
Title
VAS index indicating pain value 7 days after surgery
Description
The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.
Time Frame
7 days after surgery
Title
Maximum mouth opening at baseline
Description
The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus.
Time Frame
Before surgery
Title
Change in maximum mouth opening between baseline and 3 days after surgery
Description
The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus
Time Frame
3 days after surgery
Title
Change in maximum mouth opening between baseline and 7 days after surgery
Description
The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus
Time Frame
7 days after surgery
Title
Mean Facial Landmark Length at baseline
Description
Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.
Time Frame
Before surgery
Title
Mean Facial Landmark Length 3 days after operation
Description
Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.
Time Frame
3 days after operation
Title
Mean Facial Landmark Length 7 days after operation
Description
Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.
Time Frame
7 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Older than 18 of age Healthy patients (ASA PS index ≤ 2) The impacted mandibular third molar (IMTM) had to be in the "deep molars" ≥ 2 (according to Montero classification) Absence of acute inflammation and/or infection in the IMTM areas No history of NSAID usage four weeks before surgery Exclusion Criteria: Those with systemic conditions or pharmacologic treatments that alter oral microbiota or immunologic response Pregnant or breastfeeding women Those with the presence of any neoplastic lesion (benign or malignant), clinically or radiologically, at the extraction site or close to the IMTM Those with the presence of any radiolucent lesion larger than 1cm at the IMTM Those absent of the adjacent teeth Lack of compliance
Facility Information:
Facility Name
National Hospital of Odonto-Stomatology, Ho Chi Minh City
City
Ho Chi Minh City
State/Province
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29378982
Citation
Asutay F, Yolcu U, Gecor O, Acar AH, Ozturk SA, Malkoc S. An evaluation of effects of platelet-rich-fibrin on postoperative morbidities after lower third molar surgery. Niger J Clin Pract. 2017 Dec;20(12):1531-1536. doi: 10.4103/1119-3077.181400.
Results Reference
background
PubMed Identifier
28438151
Citation
Gulsen U, Senturk MF. Effect of platelet rich fibrin on edema and pain following third molar surgery: a split mouth control study. BMC Oral Health. 2017 Apr 24;17(1):79. doi: 10.1186/s12903-017-0371-8.
Results Reference
background
PubMed Identifier
32950350
Citation
Zhu J, Zhang S, Yuan X, He T, Liu H, Wang J, Xu B. Effect of platelet-rich fibrin on the control of alveolar osteitis, pain, trismus, soft tissue healing, and swelling following mandibular third molar surgery: an updated systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2021 Mar;50(3):398-406. doi: 10.1016/j.ijom.2020.08.014. Epub 2020 Sep 16.
Results Reference
result

Learn more about this trial

The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin)

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