Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Neurosensory Activity
研究概览
简要总结
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.
详细描述
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, Care Provider)
盲法说明
In order to maintain the blindness of subjects and the main surgeon, the drugs will be delivered in an identical brown non-translucent bag. The only one who will know about the assignament will be the second researcher.
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with dentomaxillofacial anomalies who present a complete mandibular dental arch and who have not undergone previous mandibular surgery.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Orthognathic Surgery (Procedure)
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.
干预措施: Centrum (Drug)
Melatonin
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
干预措施: Orthognathic Surgery (Procedure)
Melatonin
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
干预措施: Melatonin 10 MG Oral Tablet (Drug)
Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
干预措施: Orthognathic Surgery (Procedure)
Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
干预措施: Hydroxycobalamin (Drug)
Placebo
The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
干预措施: Orthognathic Surgery (Procedure)
结局指标
主要结局
Neurosensory Activity
时间窗: 18 month postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
次要结局
- Subjective Test(pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.)
- Objetive Test(pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.)
研究者
Pedro Sole Ventura
Principal Investigator, Surgeon
Universitat Internacional de Catalunya