Clinical trial NCT05536596: Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
Official title: Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Retrognathism
Prognathism
Orthognathic Surgery
Neurosensory Disorder
Keywords: Bilateral Sagittal Split Osteotomy
Neurosensory Disturbances
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Universidad de los Andes, Chile
First posted: 2022-09-13
Enrollment: 220
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Neurosensory Activity
timeFrame: pre-operative
measure: Neurosensory Activity
timeFrame: 1 day postoperative
measure: Neurosensory Activity
timeFrame: 3 day postoperative
measure: Neurosensory Activity
timeFrame: 2 weeks postoperative.
measure: Neurosensory Activity
timeFrame: 1 month postoperative
measure: Neurosensory Activity
timeFrame: 2 month postoperative
measure: Neurosensory Activity
timeFrame: 6 month postoperative
measure: Neurosensory Activity
timeFrame: 12 month postoperative
measure: Neurosensory Activity
timeFrame: 18 month postoperative
Secondary outcomes:
measure: Subjective Test
timeFrame: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
measure: Objetive Test
timeFrame: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Los Andes
name: Pedro Sole, DMD, OMFS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alolayan AB, Leung YY. Resolution of neurosensory deficit after mandibular orthognathic surgery: A prospective longitudinal study. J Craniomaxillofac Surg. 2017 May;45(5):755-761. doi: 10.1016/j.jcms.2017.01.032. Epub 2017 Feb 12.
citation: Teerijoki-Oksa T, Jaaskelainen SK, Forssell K, Forssell H, Vahatalo K, Tammisalo T, Virtanen A. Risk factors of nerve injury during mandibular sagittal split osteotomy. Int J Oral Maxillofac Surg. 2002 Feb;31(1):33-9. doi: 10.1054/ijom.2001.0157.
citation: da Costa Senior O, Gemels B, Van der Cruyssen F, Agbaje JO, De Temmerman G, Shaheen E, Lambrichts I, Politis C. Long-term neurosensory disturbances after modified sagittal split osteotomy. Br J Oral Maxillofac Surg. 2020 Oct;58(8):986-991. doi: 10.1016/j.bjoms.2020.05.010. Epub 2020 Jul 4.
citation: Seddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. doi: 10.1136/bmj.2.4260.237. No abstract available.
citation: Schlund M, Grall P, Ferri J, Nicot R. Effect of modified bilateral sagittal split osteotomy on inferior alveolar nerve neurosensory disturbance. Br J Oral Maxillofac Surg. 2022 Oct;60(8):1086-1091. doi: 10.1016/j.bjoms.2022.04.001. Epub 2022 Apr 13.
citation: Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.
citation: Yoshioka I, Tanaka T, Khanal A, Habu M, Kito S, Kodama M, Oda M, Wakasugi-Sato N, Matsumoto-Takeda S, Seta Y, Tominaga K, Sakoda S, Morimoto Y. Correlation of mandibular bone quality with neurosensory disturbance after sagittal split ramus osteotomy. Br J Oral Maxillofac Surg. 2011 Oct;49(7):552-6. doi: 10.1016/j.bjoms.2010.09.014. Epub 2010 Nov 10.
citation: van Merkesteyn JP, Zweers A, Corputty JE. Neurosensory disturbances one year after bilateral sagittal split mandibular ramus osteotomy performed with separators. J Craniomaxillofac Surg. 2007 Jun-Jul;35(4-5):222-6. doi: 10.1016/j.jcms.2007.04.006. Epub 2007 Jul 30.
citation: Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.
citation: Panula K, Finne K, Oikarinen K. Neurosensory deficits after bilateral sagittal split ramus osteotomy of the mandible--influence of soft tissue handling medial to the ascending ramus. Int J Oral Maxillofac Surg. 2004 Sep;33(6):543-8. doi: 10.1016/j.ijom.2003.11.005.