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

NCT05536596 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-09-13

No results posted yet for this study

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.

Conditions

  • Retrognathism
  • Prognathism
  • Orthognathic Surgery
  • Neurosensory Disorder

Interventions

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.

Sponsors & Collaborators

  • Universidad de los Andes, Chile

    collaborator OTHER

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • Pedro Sole, DMD, OMFS · Universidad de Los Andes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-06-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536596 on ClinicalTrials.gov