Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
2022年9月8日 更新者：Pedro Sole Ventura、Universitat Internacional de Catalunya
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial
The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery.
Nevertheless, one of its main complications is neurosensory damage to the inferior alveolar nerve, which can cause severe impact in the quality of life on patients who suffer from it permanently.
The purpose of this randomized clinical trial is to provide rigorous scientific evidence of the pharmacological effect of 1) Melatonin, 2) combination uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxycobalamin (UTP/CMP/hydroxycobalamin) and 3) hydroxycobalamin regarding neurosensory disturbances incidence and persistence after BSSO.
研究概览
地位
尚未招聘
详细说明
The study will be done according to the international standards of the Helsinki convention for medical research and approved by the scientific ethics committee of Universidad de los Andes Clinic.
All subjects will give their signed consent to participate of this clinical research.
This clinical randomized trial will be double-blinded as both the patient and the surgeon will not know the treatment used until the experiment is over. The randomization will be done using "random.org" software to assign participants into 4 groups. Groups A, B and C will receive the medication, whereas the Group P will receive a placebo.
研究类型
介入性
注册 (预期的)
220
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pedro Sole, DMD, OMFS
- 电话号码：+56 9 9235 2728
- 邮箱：psole@uic.es
研究联系人备份
- 姓名：Maximiliano Bravo, DMD
- 电话号码：+56 9 7690 0878
- 邮箱：mabravo9@uc.cl
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 至 70年 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria: Patients with dentomaxillofacial anomalies who present a complete mandibular dental arch and who have not undergone previous mandibular surgery.
Exclusion Criteria:
patients who:
- do not have sufficient information in their clinical records
- cannot be contacted
- do not attend their check-ups (for at least 24 postoperative months in cases with DNS)
- have refused consent to the use of their information for purposes of research.
- already undergoing Orthognathic Surgery
- with systemic conditions prone to alter recovery patterns or serious systemic diseases (decompensated metabolic disorders; neoplasms; osteodysplasias; neuropathies).
- pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Citoneurone
Groups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneurone).
One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.
|
Prognathism/Retrognathism correction through surgical procedures
其他名称：
Groups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneuron).
One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.
其他名称：
|
|
实验性的：Melatonin
Group B will receive the pharmacology treatment with 10 mg Melatonin.
One capsule orally at night for 60 days.
|
Prognathism/Retrognathism correction through surgical procedures
其他名称：
Group B will receive the pharmacology treatment with 10 mg Melatonin.
One capsule orally at night for 60 days.
|
|
实验性的：Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12).
One capsule daily for 60 days.
|
Prognathism/Retrognathism correction through surgical procedures
其他名称：
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12).
One capsule daily for 60 days.
|
|
安慰剂比较：Placebo
The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
|
Prognathism/Retrognathism correction through surgical procedures
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Neurosensory Activity
大体时间：pre-operative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
pre-operative
|
|
Neurosensory Activity
大体时间：1 day postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
1 day postoperative
|
|
Neurosensory Activity
大体时间：3 day postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
3 day postoperative
|
|
Neurosensory Activity
大体时间：2 weeks postoperative.
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
2 weeks postoperative.
|
|
Neurosensory Activity
大体时间：1 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
1 month postoperative
|
|
Neurosensory Activity
大体时间：2 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
2 month postoperative
|
|
Neurosensory Activity
大体时间：6 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
6 month postoperative
|
|
Neurosensory Activity
大体时间：12 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
12 month postoperative
|
|
Neurosensory Activity
大体时间：18 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
18 month postoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subjective Test
大体时间：pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
Subjective testing using a questionnaire and visual analogue scale.
0 = normal sensation, 10= more severe sensory deficit.
|
pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
|
Objetive Test
大体时间：pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
The Semmes-Weinstein (SW) test of sensitivity to touch/pressure will be used.
|
pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pedro Sole, DMD, OMFS、Universidad de Los Andes
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.
- Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.
- Alolayan AB, Leung YY. Resolution of neurosensory deficit after mandibular orthognathic surgery: A prospective longitudinal study. J Craniomaxillofac Surg. 2017 May;45(5):755-761. doi: 10.1016/j.jcms.2017.01.032. Epub 2017 Feb 12.
- Teerijoki-Oksa T, Jaaskelainen SK, Forssell K, Forssell H, Vahatalo K, Tammisalo T, Virtanen A. Risk factors of nerve injury during mandibular sagittal split osteotomy. Int J Oral Maxillofac Surg. 2002 Feb;31(1):33-9. doi: 10.1054/ijom.2001.0157.
- da Costa Senior O, Gemels B, Van der Cruyssen F, Agbaje JO, De Temmerman G, Shaheen E, Lambrichts I, Politis C. Long-term neurosensory disturbances after modified sagittal split osteotomy. Br J Oral Maxillofac Surg. 2020 Oct;58(8):986-991. doi: 10.1016/j.bjoms.2020.05.010. Epub 2020 Jul 4.
- Seddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. doi: 10.1136/bmj.2.4260.237. No abstract available.
- Schlund M, Grall P, Ferri J, Nicot R. Effect of modified bilateral sagittal split osteotomy on inferior alveolar nerve neurosensory disturbance. Br J Oral Maxillofac Surg. 2022 Oct;60(8):1086-1091. doi: 10.1016/j.bjoms.2022.04.001. Epub 2022 Apr 13.
- Yoshioka I, Tanaka T, Khanal A, Habu M, Kito S, Kodama M, Oda M, Wakasugi-Sato N, Matsumoto-Takeda S, Seta Y, Tominaga K, Sakoda S, Morimoto Y. Correlation of mandibular bone quality with neurosensory disturbance after sagittal split ramus osteotomy. Br J Oral Maxillofac Surg. 2011 Oct;49(7):552-6. doi: 10.1016/j.bjoms.2010.09.014. Epub 2010 Nov 10.
- van Merkesteyn JP, Zweers A, Corputty JE. Neurosensory disturbances one year after bilateral sagittal split mandibular ramus osteotomy performed with separators. J Craniomaxillofac Surg. 2007 Jun-Jul;35(4-5):222-6. doi: 10.1016/j.jcms.2007.04.006. Epub 2007 Jul 30.
- Panula K, Finne K, Oikarinen K. Neurosensory deficits after bilateral sagittal split ramus osteotomy of the mandible--influence of soft tissue handling medial to the ascending ramus. Int J Oral Maxillofac Surg. 2004 Sep;33(6):543-8. doi: 10.1016/j.ijom.2003.11.005.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年9月30日
初级完成 (预期的)
2024年6月30日
研究完成 (预期的)
2024年12月31日
研究注册日期
首次提交
2022年9月1日
首先提交符合 QC 标准的
2022年9月8日
首次发布 (实际的)
2022年9月13日
研究记录更新
最后更新发布 (实际的)
2022年9月13日
上次提交的符合 QC 标准的更新
2022年9月8日
最后验证
2022年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PISV01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be available due to anonymity and ethical considerations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Orthognathic Surgery的临床试验
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
-
Seoul National University HospitalJohnson & Johnson Medical Companies完全的