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

8. september 2022 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Forventet)

220

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

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

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universitat Internacional de Catalunya

Samarbeidspartnere

Universidad de los Andes, Chile

Etterforskere

  • Hovedetterforsker: Pedro Sole, DMD, OMFS, Universidad De Los Andes

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

30. september 2022

Primær fullføring (Forventet)

30. juni 2024

Studiet fullført (Forventet)

31. desember 2024

Datoer for studieregistrering

Først innsendt

1. september 2022

Først innsendt som oppfylte QC-kriteriene

8. september 2022

Først lagt ut (Faktiske)

13. september 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. september 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2022

Sist bekreftet

1. september 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PISV01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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