- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07788976
Mandibular Medial Osteotomy Modifications and Postoperative Stability
The Effect of Mandibular Medial Osteotomy Modifications on Postoperative Stability Following Orthognathic Surgery
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Emine Fulya Akkoyun, Dr.
- Telefonnummer: +905372676871
- E-post: efulyaakkoyun@hotmail.com
Studieorter
-
-
Fatih
-
Istanbul, Fatih, Turkiet (Türkiye), 34093
- Rekrytering
- Bezmialem Vakif University
-
Kontakt:
- Emine Fulya Akkoyun, Dr.
- Telefonnummer: +905372676871
- E-post: efulyaakkoyun@hotmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Skeletal Relapse
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
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
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E.224971
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .