NCT05536596

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

Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 13 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Retrognathism
• Prognathism
• Orthognathic Surgery
• Neurosensory Disorder

Interventions

Type	Name	Description
PROCEDURE	Orthognathic Surgery	Prognathism/Retrognathism correction through surgical procedures
DRUG	Melatonin 10 MG Oral Tablet	Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
DRUG	Hydroxycobalamin	Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
DRUG	Centrum	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.

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2022-09-13
• Last updated: 2022-09-13