Neurosensory Disorder, Orthognathic Surgery, Prognathism, Retrognathism
Conditions
Keywords
Bilateral Sagittal Split Osteotomy, Neurosensory Disturbances
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.
Interventions
PROCEDUREOrthognathic Surgery
Prognathism/Retrognathism correction through surgical procedures
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
DRUGHydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
DRUGCentrum
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
Universidad de los Andes, Chile
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurosensory Activity | pre-operative | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactPedro Sole, DMD, OMFS
Backup ContactMaximiliano Bravo, DMD
Outcome results
None listed