Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, Xi'an, China.
Department of Oral and Maxillofacial Surgery, College of Stomatology, Xi'an Jiaotong University, Xi'an, Shaanxi, 710004, China.
BMC Oral Health. 2022 Aug 30;22(1):368. doi: 10.1186/s12903-022-02408-7.
The surgical extraction of impacted third molars is one of the most common procedures in oral and maxillofacial surgery, which associated with several postoperative complications. The aim of this clinical trial was to estimate the implication of concentrated growth factor (CGF) on postoperative sequelae after the completely impacted lower third molar extraction.
A total of 74 sides of 37 participants who had completely bilateral impacted lower third molars were enrolled in this split-mouth, randomized single‑blind, clinical trial. Surgical extraction was undertaken on both sides of the mandible. Randomization was achieved by opaque, sealed envelopes. The postoperative outcomes including wound healing, swelling and pain were clinically assessed at different-time intervals(1st, 3rd and 7th days). A p-value < 0.05 was considered statistically significant.
The wound healing index was significantly better in the test sides (P = 0.001). Regarding the facial swelling, the test sides had significantly less values than the control sides, particularly on the 1st (1.01 ± .57 vs. 1.55 ± .56) and 3rd days (1.42 ± 0.8 vs. 2.63 ± 1.2) postoperatively. Nonetheless, the swelling was disappeared within the 7th day in both sides. The pain scores of visual analog scale were no a statistically significant difference between both sides on the 1st day, meanwhile, the pain scores were significantly lower in the test sides compared with the control sides, especially on the 3rd (P = 0.001) and 7th days (P < 0.001) postoperatively.
The application of CGF following the surgical extraction of lower third molar has accelerated the healing of soft tissues as well as reduced postoperative sequelae such as swelling and pain. Therefore, the CGF could be promoted among clinicians during the lower third molar surgical extraction.
This study was registered with the TCTR identification number TCTR20210325002 on 25/03/2021 at Thai Clinical Trials Register-Medical Research Foundation of Thailand (MRF). Also it was ethically approved from the institutional ethics committee at the Hospital of Stomatology, Xian Jiaotong University, Xian, China (No: 032), and has been conducted in accordance to the guidelines of the declaration of Helsinki. Written informed consent was obtained from all participants in the study.
下颌阻生第三磨牙的外科拔除是口腔颌面外科最常见的手术之一,其术后并发症较多。本临床试验旨在评估浓缩生长因子(CGF)对完全埋伏下颌第三磨牙拔除术后后遗症的影响。
本研究共纳入 37 名双侧完全埋伏下颌第三磨牙患者的 74 侧下颌骨,采用分侧、随机、单盲临床试验设计。下颌骨双侧均行手术拔除。采用不透明密封信封进行随机分组。术后不同时间(第 1、3、7 天)对伤口愈合、肿胀和疼痛等术后结局进行临床评估。P 值<0.05 被认为具有统计学意义。
实验组的伤口愈合指数明显优于对照组(P = 0.001)。在面部肿胀方面,实验组的数值明显小于对照组,尤其是在术后第 1 天(1.01 ± 0.57 vs. 1.55 ± 0.56)和第 3 天(1.42 ± 0.8 vs. 2.63 ± 1.2)。然而,两侧肿胀均在第 7 天内消失。术后第 1 天,两组的视觉模拟评分疼痛无统计学差异,然而实验组的疼痛评分明显低于对照组,尤其是在术后第 3 天(P = 0.001)和第 7 天(P<0.001)。
在拔除下颌第三磨牙后应用 CGF 可加速软组织愈合,并减少术后肿胀和疼痛等后遗症。因此,在拔除下颌第三磨牙时,CGF 可在临床医生中推广。
本研究于 2021 年 3 月 25 日在泰国临床试验注册中心(TCTR)以 TCTR20210325002 号注册,并经中国西安交通大学口腔医院机构伦理委员会批准(编号:032),符合《赫尔辛基宣言》的指导原则。所有参与研究的患者均签署了书面知情同意书。