- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07788976
Mandibular Medial Osteotomy Modifications and Postoperative Stability
The Effect of Mandibular Medial Osteotomy Modifications on Postoperative Stability Following Orthognathic Surgery
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This study aims to evaluate and compare the effects of two different medial mandibular osteotomy modifications, namely the Hunsuck and Posnick techniques, on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery.
Patients who meet the study eligibility criteria and are scheduled to undergo bilateral sagittal split ramus osteotomy (BSSO) as part of orthognathic surgery will be included. Depending on the medial mandibular osteotomy technique used, patients will be evaluated in two groups: those undergoing the Hunsuck modification and those undergoing the Posnick modification.
Preoperative and postoperative radiographic records will be evaluated to assess skeletal changes associated with each osteotomy technique. Postoperative skeletal stability will be assessed by comparing relevant mandibular and skeletal reference points and angular measurements between the preoperative, immediate postoperative, and follow-up imaging records. The amount and direction of postoperative skeletal relapse will be determined based on changes occurring during the follow-up period.
The primary objective is to determine whether the Hunsuck and Posnick modifications differ in terms of postoperative skeletal stability and relapse following orthognathic surgery. Secondary evaluations may include assessment of the magnitude and direction of mandibular positional changes and comparison of the radiographic outcomes between the two techniques.
The findings of this study may provide clinically relevant information regarding the influence of medial mandibular osteotomy design on postoperative skeletal stability and may help guide the selection of an appropriate osteotomy technique in orthognathic surgery.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Emine Fulya Akkoyun, Dr.
- Numero di telefono: +905372676871
- Email: efulyaakkoyun@hotmail.com
Luoghi di studio
-
-
Fatih
-
Istanbul, Fatih, Turchia (Türkiye), 34093
- Reclutamento
- Bezmialem Vakif University
-
Contatto:
- Emine Fulya Akkoyun, Dr.
- Numero di telefono: +905372676871
- Email: efulyaakkoyun@hotmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients with an indication for orthognathic surgery who are planned to undergo bimaxillary orthognathic surgery.
- Patients who have undergone preoperative orthodontic treatment.
- Patients aged 18-65 years.
Exclusion Criteria:
- Patients who develop an unfavorable split (bad split) during surgery.
- Patients with cleft lip and palate, craniofacial syndromes, or a history of facial trauma.
- Patients who have previously undergone orthognathic surgery and require revision surgery.
- Patients whose computed tomography (CT) records are inadequate for the required measurements.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Hunsuck Modification Group
Patients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Hunsuck modification.
The osteotomy will be performed according to the Hunsuck technique, with the medial horizontal osteotomy terminating at the level of the lingula and extending posteriorly to facilitate the sagittal split.
Postoperative skeletal stability and relapse will be evaluated during the follow-up period.
|
Bilateral sagittal split ramus osteotomy will be performed as part of orthognathic surgery to correct the planned mandibular skeletal deformity.
The mandibular ramus and body will be divided using the assigned medial osteotomy modification (Hunsuck or Posnick), followed by sagittal splitting of the mandible.
The distal mandibular segment will then be repositioned according to the preoperative surgical plan and stabilized using appropriate osteosynthesis.
Postoperative skeletal stability and mandibular relapse will be evaluated during the follow-up period.
The Hunsuck modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO).
The medial horizontal osteotomy will be initiated at the lingula and extended posteriorly for a short distance, according to the Hunsuck modification.
The remaining steps of the BSSO will be performed using the standard surgical technique.
Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations
|
|
Comparatore attivo: Posnick Modification Group
Patients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Posnick modification.
The osteotomy will be performed according to the Posnick technique, with the modified medial osteotomy design extending posteriorly in accordance with the technique.
Postoperative skeletal stability and relapse will be evaluated during the follow-up period.
|
Bilateral sagittal split ramus osteotomy will be performed as part of orthognathic surgery to correct the planned mandibular skeletal deformity.
The mandibular ramus and body will be divided using the assigned medial osteotomy modification (Hunsuck or Posnick), followed by sagittal splitting of the mandible.
The distal mandibular segment will then be repositioned according to the preoperative surgical plan and stabilized using appropriate osteosynthesis.
Postoperative skeletal stability and mandibular relapse will be evaluated during the follow-up period.
The Posnick modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO).
The medial horizontal osteotomy will be performed according to the Posnick modification, with the osteotomy design extending posteriorly along the medial aspect of the mandibular ramus as described for this technique.
The remaining steps of the BSSO will be performed using the standard surgical technique.
Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Skeletal Relapse
Lasso di tempo: 1 year
|
The primary outcome will be the amount and percentage of skeletal relapse between 1 month and 12 months after orthognathic surgery (T3-T1), assessed using three-dimensional cephalometric and skeletal measurements.
|
1 year
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- E.224971
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .