Clinical trial NCT05536596: Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
Official title: Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial
Conditions: Retrognathism
Prognathism
Orthognathic Surgery
Neurosensory Disorder
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.
Interventions:
description: Prognathism/Retrognathism correction through surgical procedures
name: Orthognathic Surgery
other_name: Bilateral Sagittal Split Osteotomy
type: Procedure
description: Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
name: Melatonin 10 MG Oral Tablet
type: Drug
description: Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
name: Hydroxycobalamin
type: Drug
description: 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.
name: Centrum
other_name: Citoneurone [Cytidine + Hydroxocobalamin, + Uridine]
type: Drug
Study arms:
design_group_description: 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.
design_group_title: Citoneurone
design_group_type: Experimental
design_group_description: Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
design_group_title: Melatonin
design_group_type: Experimental
design_group_description: Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
design_group_title: Hydroxycobalamin
design_group_type: Experimental
design_group_description: The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Universitat Internacional de Catalunya
Collaborators: Universidad de los Andes (Chile)
Drug name mappings:
name: 褪黑素
lang: CN
name: Melatonin
lang: EN
name: メラトニン
lang: JP
name: 羟钴胺
lang: CN
name: Hydroxocobalamin
lang: EN
name: ヒドロキソコバラミン
lang: JP