PRFPhase 4A-PRF+NCT05824793
The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin)
A Phase 4 study testing A-PRF+ in people with PRF, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PRF
- What is being tested?
- A-PRF+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2019to 30 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
National Hospital of Odonto-Stomatology, Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh, 70000
About this study
Official title: The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars: a Randomized Controlled Trial
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.
Read the 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).
- Conditions
- PRF
- Being tested
- A-PRF+
- Keywords
- Impacted mandibular third molar, tooth extraction, A-PRF+, pain, trismus, swelling
- Medical subject headings
- Pain, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRF+Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants had their impacted mandibular third molar (IMTM) extracted according to the standard procedure. |
| Experimental Group | Experimental | 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. Receives: Combination Product: A-PRF+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours immediately after the lips stopped feeling numb
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.
Measured: 4 hours immediately after the lips stopped feeling numb
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.
Measured: 6 hours immediately after the lips stopped feeling numb
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.
Measured: 1 day after surgery
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.
Measured: 3 days after surgery
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.
Measured: 7 days after surgery
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.
Measured: Before surgery
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
Measured: 3 days after surgery
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
Measured: 7 days after surgery
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.
Measured: Before surgery
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.
Measured: 3 days after operation
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.
Measured: 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Oct 2019
- Primary completion23 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PRFStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thi Bich Ly, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824793
- Sponsor's protocol ID
- 194/ĐHYD-HĐĐĐ
- Acronym
- A-PRF+
- Status last verified
- Apr 2023
- First submitted
- 25 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29378982Gulsen 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.
PubMed 28438151Zhu 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.
PubMed 32950350
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05824793
- Acronym / sponsor ID
- A-PRF+ / 194/ĐHYD-HĐĐĐ
- Conditions
- PRF
- Keywords
- Impacted mandibular third molar, tooth extraction, A-PRF+, pain, trismus, swelling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants had their impacted mandibular third molar (IMTM) extracted according to the standard procedure. |
| Experimental Group | Experimental | Combination Product: A-PRF+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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-PRF+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. | Combination product | Experimental Group |
Primary outcome
VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before 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 3 days after surgery
Time frame: 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
Time frame: 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
Time frame: Before surgery
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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 29378982Asutay 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.
- Background: PubMed 28438151Gulsen 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 publication: PubMed 32950350Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A-PRF+ in people with PRF, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb (time frame: 2 hours immediately after the lips stopped feeling numb). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824793, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.