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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05536596
Study type Interventional
Source Universitat Internacional de Catalunya
Contact Pedro Sole, DMD, OMFS
Phone +56 9 9235 2728
Email psole@uic.es
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date September 30, 2022
Completion date December 31, 2024

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