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

NCT05824793 | Completed Phase 4

• 1 other identifier: 194/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

PRF

Keywords

Impacted mandibular third molar; tooth extraction; A-PRF+; pain; trismus; swelling

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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.

  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.

  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.

  7 days after operation

Study Arms (2)

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.

Combination Product: A-PRF+

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

National Hospital of Odonto-Stomatology, Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 29378982 BACKGROUND

• 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.

  PMID: 28438151 BACKGROUND

• 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.

  PMID: 32950350 RESULT

MeSH Terms

Conditions

Pain; Trismus

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer/Dr

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 24, 2023
• Study Start: October 1, 2019
• Primary Completion: April 23, 2021
• Study Completion: April 30, 2021
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)