The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in maximum mouth opening between baseline and 3 days after surgery
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in maximum mouth opening between baseline and 3 days after surgery
时间窗: 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
VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb
时间窗: 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 7 days after surgery
时间窗: 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
时间窗: 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 7 days after surgery
时间窗: 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
时间窗: 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.
VAS index indicating pain value 4 hours immediately after the lips stopped feeling numb
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Mean Facial Landmark Length 3 days after operation
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Nguyen Thi Bich Ly
Senior Lecturer/Dr
University of Medicine and Pharmacy at Ho Chi Minh City