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| Name | Class |
|---|---|
| Universidad de los Andes, Chile | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citoneurone | Experimental | 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. |
|
| Melatonin | Experimental | Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days. |
|
| Hydroxycobalamin | Experimental | Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days. |
|
| Placebo | Placebo Comparator | The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthognathic Surgery | Procedure | Prognathism/Retrognathism correction through surgical procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | pre-operative |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 1 day postoperative |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 3 day postoperative |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 2 weeks postoperative. |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 1 month postoperative |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 2 month postoperative |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 6 month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Test | Subjective testing using a questionnaire and visual analogue scale. 0 = normal sensation, 10= more severe sensory deficit. | pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery. |
| Objetive Test |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Sole, DMD, OMFS | Contact | +56 9 9235 2728 | psole@uic.es | |
| Maximiliano Bravo, DMD | Contact | +56 9 7690 0878 | mabravo9@uc.cl |
| Name | Affiliation | Role |
|---|---|---|
| Pedro Sole, DMD, OMFS | Universidad de Los Andes | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28318920 | Background | 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. | |
| 11936397 | Background | 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. |
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Individual participant data will not be available due to anonymity and ethical considerations.
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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.
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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.
|
| Melatonin 10 MG Oral Tablet | Drug | Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days. |
|
| Hydroxycobalamin | Drug | Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days. |
|
| Centrum | Drug | 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. |
|
|
| Neurosensory Activity |
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others |
| 12 month postoperative |
| Neurosensory Activity | Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others | 18 month postoperative |
The Semmes-Weinstein (SW) test of sensitivity to touch/pressure will be used.
| pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery. |
| 32631751 | Background | 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. |
| 20784403 | Background | 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. |
| 35606209 | Background | 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. |
| 11078134 | Background | 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. |
| 21071118 | Background | 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. |
| 17681774 | Background | 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. |
| 17719387 | Background | 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. |
| 15308252 | Background | 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. |
| ID | Term |
|---|---|
| D063173 | Retrognathia |
| D011378 | Prognathism |
| D012678 | Sensation Disorders |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057909 | Orthognathic Surgery |
| D008550 | Melatonin |
| D013607 | Tablets |
| D006879 | Hydroxocobalamin |
| D003562 | Cytidine |
| D014529 | Uridine |
| ID | Term |
|---|---|
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D014805 | Vitamin B 12 |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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