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

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536596
• Other study ID #: PISV01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Universitat Internacional de Catalunya
• Contact: Pedro Sole, DMD, OMFS
• Phone: +56 9 9235 2728
• Email: psole[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurosensory Disorder
• Orthognathic Surgery
• Prognathism
• Retrognathia
• Retrognathism

Intervention

Procedure:
• Orthognathic Surgery
Prognathism/Retrognathism correction through surgical procedures

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.
• Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Universidad de los Andes, Chile

References & Publications (10)

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. — View 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. Review. — View 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. — View 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. — View 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 Apr 13. pii: S0266-4356(22)00102-4. doi: 10.1016/j.bjoms.2022.04.001. [Epub ahead of print] — View Citation

Seddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. — View Citation

Teerijoki-Oksa T, Jääskeläinen SK, Forssell K, Forssell H, Vähätalo 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. — View 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. Epub 2007 Jul 30. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	pre-operative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	1 day postoperative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	3 day postoperative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	2 weeks postoperative.
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	1 month postoperative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	2 month postoperative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	6 month postoperative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	12 month postoperative
Primary	Neurosensory Activity	Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others	18 month postoperative
Secondary	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.
Secondary	Objetive Test	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.