- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07788976
Mandibular Medial Osteotomy Modifications and Postoperative Stability
The Effect of Mandibular Medial Osteotomy Modifications on Postoperative Stability Following Orthognathic Surgery
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Emine Fulya Akkoyun, Dr.
- 전화번호: +905372676871
- 이메일: efulyaakkoyun@hotmail.com
연구 장소
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Fatih
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Istanbul, Fatih, 터키 (Türkiye), 34093
- 모병
- Bezmialem Vakif University
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연락하다:
- Emine Fulya Akkoyun, Dr.
- 전화번호: +905372676871
- 이메일: efulyaakkoyun@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Skeletal Relapse
기간: 1 year
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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.
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1 year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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