Clinical trial NCT05824793: The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: PRF
Keywords: Impacted mandibular third molar
tooth extraction
A-PRF+
pain
trismus
swelling
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb
timeFrame: 2 hours immediately after the lips stopped feeling numb
measure: VAS index indicating pain value 4 hours immediately after the lips stopped feeling numb
timeFrame: 4 hours immediately after the lips stopped feeling numb
measure: VAS index indicating pain value 6 hours immediately after the lips stopped feeling numb
timeFrame: 6 hours immediately after the lips stopped feeling numb
measure: VAS index indicating pain value 1 day after surgery
timeFrame: 1 day after surgery
measure: VAS index indicating pain value 3 days after surgery
timeFrame: 3 days after surgery
measure: VAS index indicating pain value 7 days after surgery
timeFrame: 7 days after surgery
measure: Maximum mouth opening at baseline
timeFrame: Before surgery
measure: Change in maximum mouth opening between baseline and 3 days after surgery
timeFrame: 3 days after surgery
measure: Change in maximum mouth opening between baseline and 7 days after surgery
timeFrame: 7 days after surgery
measure: Mean Facial Landmark Length at baseline
timeFrame: Before surgery
measure: Mean Facial Landmark Length 3 days after operation
timeFrame: 3 days after operation
measure: Mean Facial Landmark Length 7 days after operation
timeFrame: 7 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: National Hospital of Odonto-Stomatology, Ho Chi Minh City
state: Ho Chi Minh
Study officials:
References:
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.
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.
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.