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

Universitat Internacional de Catalunya

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Neurosensory Disorder; Retrognathism; Orthognathic Surgery; Prognathism

Treatments: Drug: Melatonin 10 MG Oral Tablet; Procedure: Orthognathic Surgery; Drug: Centrum; Drug: Hydroxycobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT05536596

PISV01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 13 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups, including a placebo group

Citoneurone

Experimental 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.

Treatment:

Drug: Centrum

Procedure: Orthognathic Surgery

Melatonin

Experimental group

Description:

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

Treatment:

Drug: Melatonin 10 MG Oral Tablet

Procedure: Orthognathic Surgery

Hydroxycobalamin

Experimental group

Description:

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

Treatment:

Procedure: Orthognathic Surgery

Drug: Hydroxycobalamin

Placebo

Placebo Comparator group

Description:

The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.

Treatment:

Procedure: Orthognathic Surgery