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

8. september 2022 opdateret af: Pedro Sole Ventura, Universitat Internacional de Catalunya

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

220

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Pedro Sole, DMD, OMFS
  • Telefonnummer: +56 9 9235 2728
  • E-mail: psole@uic.es

Undersøgelse Kontakt Backup

  • Navn: Maximiliano Bravo, DMD
  • Telefonnummer: +56 9 7690 0878
  • E-mail: mabravo9@uc.cl

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Orthognathic Surgery
Prognathism/Retrognathism correction through surgical procedures
Andre navne:
  • Bilateral Sagittal Split Osteotomy
Medicin: 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.
Andre navne:
  • Citoneurone [Cytidine + Hydroxocobalamin, + Uridine]
Eksperimentel: Melatonin
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Procedure: Orthognathic Surgery
Prognathism/Retrognathism correction through surgical procedures
Andre navne:
  • Bilateral Sagittal Split Osteotomy
Medicin: Melatonin 10 MG Oral Tablet
Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Eksperimentel: Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
Procedure: Orthognathic Surgery
Prognathism/Retrognathism correction through surgical procedures
Andre navne:
  • Bilateral Sagittal Split Osteotomy
Medicin: Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
Placebo komparator: Placebo
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
Andre navne:
  • Bilateral Sagittal Split Osteotomy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neurosensory Activity
Tidsramme: pre-operative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
pre-operative
Neurosensory Activity
Tidsramme: 1 day postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
1 day postoperative
Neurosensory Activity
Tidsramme: 3 day postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
3 day postoperative
Neurosensory Activity
Tidsramme: 2 weeks postoperative.
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
2 weeks postoperative.
Neurosensory Activity
Tidsramme: 1 month postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
1 month postoperative
Neurosensory Activity
Tidsramme: 2 month postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
2 month postoperative
Neurosensory Activity
Tidsramme: 6 month postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
6 month postoperative
Neurosensory Activity
Tidsramme: 12 month postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
12 month postoperative
Neurosensory Activity
Tidsramme: 18 month postoperative
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
18 month postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective Test
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitat Internacional de Catalunya

Samarbejdspartnere

Universidad de los Andes, Chile

Efterforskere

  • Ledende efterforsker: Pedro Sole, DMD, OMFS, Universidad De Los Andes

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

30. september 2022

Primær færdiggørelse (Forventet)

30. juni 2024

Studieafslutning (Forventet)

31. december 2024

Datoer for studieregistrering

Først indsendt

1. september 2022

Først indsendt, der opfyldte QC-kriterier

8. september 2022

Først opslået (Faktiske)

13. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PISV01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be available due to anonymity and ethical considerations.

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