- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05536596
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Pedro Sole, DMD, OMFS
- Telefonnummer: +56 9 9235 2728
- E-post: psole@uic.es
Studera Kontakt Backup
- Namn: Maximiliano Bravo, DMD
- Telefonnummer: +56 9 7690 0878
- E-post: mabravo9@uc.cl
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Citoneurone
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.
|
Prognathism/Retrognathism correction through surgical procedures
Andra namn:
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.
Andra namn:
|
Experimentell: Melatonin
Group B will receive the pharmacology treatment with 10 mg Melatonin.
One capsule orally at night for 60 days.
|
Prognathism/Retrognathism correction through surgical procedures
Andra namn:
Group B will receive the pharmacology treatment with 10 mg Melatonin.
One capsule orally at night for 60 days.
|
Experimentell: Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12).
One capsule daily for 60 days.
|
Prognathism/Retrognathism correction through surgical procedures
Andra namn:
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12).
One capsule daily for 60 days.
|
Placebo-jämförare: Placebo
The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
|
Prognathism/Retrognathism correction through surgical procedures
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Neurosensory Activity
Tidsram: pre-operative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
pre-operative
|
Neurosensory Activity
Tidsram: 1 day postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
1 day postoperative
|
Neurosensory Activity
Tidsram: 3 day postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
3 day postoperative
|
Neurosensory Activity
Tidsram: 2 weeks postoperative.
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
2 weeks postoperative.
|
Neurosensory Activity
Tidsram: 1 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
1 month postoperative
|
Neurosensory Activity
Tidsram: 2 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
2 month postoperative
|
Neurosensory Activity
Tidsram: 6 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
6 month postoperative
|
Neurosensory Activity
Tidsram: 12 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
12 month postoperative
|
Neurosensory Activity
Tidsram: 18 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
18 month postoperative
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Subjective Test
Tidsram: 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.
|
pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
Objetive Test
Tidsram: 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.
|
pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Pedro Sole, DMD, OMFS, Universidad de Los Andes
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Medfödda abnormiteter
- Muskuloskeletala sjukdomar
- Stomatogena sjukdomar
- Avvikelser i stomatogena systemet
- Abnormaliteter i käken
- Käksjukdomar
- Maxillofaciala abnormiteter
- Kraniofaciala abnormiteter
- Muskuloskeletala abnormiteter
- Mandibular sjukdomar
- Retrognatia
- Prognatism
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Skyddsmedel
- Mikronäringsämnen
- Vitaminer
- Antioxidanter
- Vitamin B-komplex
- Hematinik
- Melatonin
- Vitamin B 12
- Hydroxokobalamin
Andra studie-ID-nummer
- PISV01
Plan för individuella deltagardata (IPD)
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