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

Sponsor

Universitat Internacional de Catalunya (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05536596

Collaborator

Universidad de los Andes, Chile (Other)

220

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retrognathism Prognathism Orthognathic Surgery Neurosensory Disorder	Procedure: Orthognathic Surgery Drug: Melatonin 10 MG Oral Tablet Drug: Hydroxycobalamin Drug: Centrum	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The participants will be assigned into 4 groups. Groups A, B and C will receive the medication (Melatonin, Hydroxycobalamin and combination UTP/CMP/hydroxycobalamin), whereas the Group P will receive placebo.The participants will be assigned into 4 groups. Groups A, B and C will receive the medication (Melatonin, Hydroxycobalamin and combination UTP/CMP/hydroxycobalamin), whereas the Group P will receive placebo.

Masking:

Double (Participant, Care Provider)

Masking Description:

In order to maintain the blindness of subjects and the main surgeon, the drugs will be delivered in an identical brown non-translucent bag. The only one who will know about the assignament will be the second researcher.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citoneurone 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.	Procedure: Orthognathic Surgery Prognathism/Retrognathism correction through surgical procedures Other Names: Bilateral Sagittal Split Osteotomy 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. Other Names: Citoneurone [Cytidine + Hydroxocobalamin, + Uridine]
Experimental: Melatonin Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.	Procedure: Orthognathic Surgery Prognathism/Retrognathism correction through surgical procedures Other Names: Bilateral Sagittal Split Osteotomy 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.
Experimental: Hydroxycobalamin Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.	Procedure: Orthognathic Surgery Prognathism/Retrognathism correction through surgical procedures Other Names: Bilateral Sagittal Split Osteotomy Drug: Hydroxycobalamin Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
Placebo Comparator: Placebo The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.	Procedure: Orthognathic Surgery Prognathism/Retrognathism correction through surgical procedures Other Names: Bilateral Sagittal Split Osteotomy

Outcome Measures

Primary Outcome Measures

Neurosensory Activity [pre-operative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [1 day postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [3 day postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [2 weeks postoperative.]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [1 month postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [2 month postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [6 month postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [12 month postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Neurosensory Activity [18 month postoperative]
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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