A Phase 2/3 interventional study of Orthognathic Surgery and Melatonin 10 MG Oral Tablet in Retrognathism, Prognathism and Orthognathic Surgery, sponsored by Universitat Internacional de Catalunya. Status unknown. Open to participants aged 13 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Universitat Internacional de Catalunya · Phase 2/3, Interventional, and Treatment
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.
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:
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 · Drug: Centrum
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Procedure: Orthognathic Surgery · Drug: Melatonin 10 MG Oral Tablet
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
Procedure: Orthognathic Surgery · Drug: Hydroxycobalamin
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
Also known as: Bilateral Sagittal Split Osteotomy
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
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.
Also known as: Citoneurone [Cytidine + Hydroxocobalamin, + Uridine]
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: pre-operative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 1 day postoperative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 3 day postoperative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 2 weeks postoperative.
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 1 month postoperative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 2 month postoperative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 6 month postoperative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 12 month postoperative
Neurosensory Activity
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
Time frame: 18 month postoperative
Subjective Test
Subjective testing using a questionnaire and visual analogue scale. 0 = normal sensation, 10= more severe sensory deficit.
Time frame: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
Objetive Test
The Semmes-Weinstein (SW) test of sensitivity to touch/pressure will be used.
Time frame: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be available due to anonymity and ethical considerations.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Universitat Internacional de Catalunya