Mandibular Medial Osteotomy Modifications and Postoperative Stability
The Effect of Mandibular Medial Osteotomy Modifications on Postoperative Stability Following Orthognathic Surgery
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Emine Fulya Akkoyun, Dr.
- Telefonní číslo: +905372676871
- E-mail: efulyaakkoyun@hotmail.com
Studijní místa
-
-
Fatih
-
Istanbul, Fatih, Turecko (Türkiye), 34093
- Nábor
- Bezmialem Vakif University
-
Kontakt:
- Emine Fulya Akkoyun, Dr.
- Telefonní číslo: +905372676871
- E-mail: efulyaakkoyun@hotmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative Skeletal Relapse
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E.224971
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .