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

Phase 2

Not yet recruiting

• Conditions: Retrognathism; Prognathism; Orthognathic Surgery; Neurosensory Disorder
• Interventions: Procedure: Orthognathic Surgery; Drug: Melatonin 10 MG Oral Tablet; Drug: Centrum; Drug: Hydroxycobalamin

• Registration Number: NCT05536596
• Lead Sponsor: Universitat Internacional de Catalunya

Brief 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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Study First Posted: 2022-09-13
• Last Update Posted: 2022-09-13
• Study Start: 2022-09-30
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Patients with dentomaxillofacial anomalies who present a complete mandibular dental arch and who have not undergone previous mandibular surgery.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Orthognathic Surgery	Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Melatonin	Melatonin 10 MG Oral Tablet	Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Hydroxycobalamin	Orthognathic Surgery	Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
Citoneurone	Orthognathic Surgery	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.
Citoneurone	Centrum	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.
Placebo	Orthognathic Surgery	The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
Hydroxycobalamin	Hydroxycobalamin	Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.

Primary Outcome Measures

Name	Time	Method
Neurosensory Activity	18 month postoperative	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

Secondary Outcome Measures

Name	Time	Method
Subjective Test	pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.	Subjective testing using a questionnaire and visual analogue scale. 0 = normal sensation, 10= more severe sensory deficit.
Objetive Test	pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.	The Semmes-Weinstein (SW) test of sensitivity to touch/pressure will be used.