Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy

Universitat Internacional de Catalunya220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Retrognathism

Interventions

Orthognathic SurgeryPROCEDURE

Prognathism/Retrognathism correction through surgical procedures

Melatonin 10 MG Oral TabletDRUG

Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.

HydroxycobalaminDRUG

Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.

CentrumDRUG

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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