Influence of Leukocyte- and Platelet Rich Fibrin (L-PRF) on the Outcomes of Impacted Mandibular Third Molar Removal Surgery: a Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Swelling change evaluation
研究概览
简要总结
The purpose of this study was to evaluate the influence of leukocyte- and platelet-rich fibrin (L-PRF) on impacted mandibular third molar (IMTM) extraction wound healing, patient postoperative discomfort, and incidence of alveolar osteitis (AO).
Thirty patients (18 female, 12 male) who met the inclusion criteria for this split-mouth study underwent bilateral IMTM surgical extractions. Following extraction, randomization was done. One socket received L-PRF, and the other socket served as a regular blood clot control. Postoperatively, the soft tissue healing index (HI), pain according to visual analog scale (VAS), facial swelling using a horizontal and vertical guide, and incidence of AO were evaluated 1, 3, 7, and 14 days after surgery.
详细描述
The study was designed as a prospective split-mouth clinical trial on patients who needed bilateral paired IMTM extractions. The study was conducted at the Maxillofacial Surgery Department of the Lithuanian University of Health Sciences. Approval by the local bioethics committee was granted (No. BEC-MF-01). All patients signed an informed consent.
Patient selection Based on previously treated pilot cases, a power analysis was conducted for sample size estimation (Statistica 6.0, Dell Software, Round Rock, TX, USA). The calculations revealed a minimum sample size of n = 30, based on a power of 90% and an α of 5%.
The inclusion criteria were as follows:
- Male and female patients with an age of 18 to 60 years;
- Healthy patients (American Society of Anesthesiologists Physical Status (ASA PS) index ≤ 2);
- Sole bilateral extractions of IMTMs during the same surgery;
- Complete root formation of tooth No. 38 and 48 at radiological examination;
- Absence of acute inflammation and/or infection in the IMTMs area;
- No history of nonsteroidal anti-inflammatory drug (NSAID) use in the past 4 weeks prior to surgery;
- Same-difficulty bilateral IMTM extractions, according to both Pederson and Juodzbalys & Daugela classifications;
- Signed informed consent.
The following exclusion criteria were used:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and Independent Outcomes Assessor were blinded to study groups. Names of participants were coded and known to Principal investigator only.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with an age of 18 to 60 years;
- •Healthy patients (American Society of Anesthesiologists Physical Status (ASA PS) index ≤ 2);
- •Sole bilateral extractions of IMTMs during the same surgery;
- •Complete root formation of tooth No. 38 and 48 at radiological examination;
- •Absence of acute inflammation and/or infection in the IMTMs area;
- •No history of nonsteroidal anti-inflammatory drug (NSAID) use in the past 4 weeks prior to surgery;
- •Same-difficulty bilateral IMTM extractions, according to both Pederson and Juodzbalys & Daugela classifications;
- •Signed informed consent.
排除标准
- •Smoking patients;
- •IMTM surgery duration difference greater than 10 minutes for each side, seeking to avoid bias;
- •Different surgical manipulations taken at each IMTM surgery site;
- •Presence of any neoplastic lesion (benign or malignant), clinically or radiologically evaluable, at the site or close to the impacted tooth;
- •Presence of any radiolucent lesion >1 cm at impacted tooth level;
- •Absence of the adjacent tooth;
- •Systemic conditions or pharmacological treatments altering oral microbiota or immunologic response;
- •Alcohol or drug abuse;
- •Pregnant or breastfeeding women;
- •Lack of compliance by the patient or any other evidence suggesting that the patient was not likely to follow the study protocol.
结局指标
主要结局
Swelling change evaluation
时间窗: 1st-, 3rd-, and 7th- postoperative day
Facial swelling clinical assessments were performed by a single blinded examiner at baseline (before surgery) and at the 1st-, 3rd-, and 7th-day visits postoperatively at approximately the same time of day. Patients were seated in a relaxed position with the inferior border of the mandible parallel to the floor. Facial swelling in the operation side was evaluated using two facial measurements with nonexpandable tape: * In the vertical dimension, measurement from the lateral canthus of the eye to the pogonion of the mandible was taken; * In the horizontal dimension, the distance from the lower border of the tragus to the mouth commissure on both operated sides was measured. Facial swelling value was taken as the average value of these two measurements. The preoperative measurement was considered as the baseline value.
Pain visual analogue scale (VAS) score change evaluation
时间窗: 1st-, 2nd-, 3rd-, 4th-, 5th-, 6th-, and 7th- postoperative day
Pain VAS scale consisted of 10 units in combination with a graphic rating scale, where the leftmost score 0 represented absence of pain and the rightmost score 10 indicated the worst possible, unbearable, excruciating pain.
Healing index change evaluation
时间窗: 1st-, 3rd-, 7th-, and 14th- postoperative day
Postextractional wound soft tissue healing was evaluated using a modified postextraction wound healing index (HI) \[24\], which considered four parameters: bleeding, suppuration, tissue color, and consistency of the healing tissue. Each parameter involved 3 scoring levels; consequently, the cumulative scoring scale ranged from 4, corresponding to excellent healing, to 12, indicating severely impaired healing. HI was evaluated clinically by the same blinded examiner at the 1st-, 3rd-, 7th-, and 14th- after surgery.
次要结局
未报告次要终点
研究者
Povilas Daugela
DDS
Lithuanian University of Health Sciences