- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04421144
Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries
연구 개요
상태
개입 / 치료
상세 설명
Intervention:
Diagnostic procedure:
All Patients will be selected according to inclusion and exclusion criteria & Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out.
Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion).
Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental casts.
A heat-cured acrylic resin stent will be constructed on the stone model. Using the stent, a radiographic stent will be constructed for imaging and planning procedures.
Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients will be referred to an orthodontist for presurgical phase of orthodontic treatment for decompensation and to attain stable occlusion in three points in the surgery.
Planning procedure:
All planning procedures are carried out by MZ and under the supervision of AH and MH.
Computer-aided planning & MCROS design for all patients: All planning will be done using specialized software .
One virtual 3D anatomic model of the patient will be constructed through thresholding & image fusion.
Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of the sagittal split of the mandible will be performed and the mandible position adjusted according to the bite registered.
After settling on the optimum virtual plan, designing of the cutting guides and titanium plates will then be started.
Intra-operative procedures:
The surgical procedures will be carried out by MZ under the supervisor of AH in the Oral & Maxillofacial operating floor on the 8th floor of the faculty of Oral & Dental Medicine new building.
Scrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006.
Local anaesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along the incision lines for hemostasis.
Access through a vestibular intraoral incision for maxilla & Sagittal split incision for mandible will be carried out. Dissection and reflection to reach the bone will be carried out.
Le Fort I Maxillary & Bilateral Sagittal split mandibular osteotomies will be carried out using the osteotomy cutting guides.
Complete mobilization of maxillary and mandibular segments. Reposition and fixation of the maxillary & mandibular segments using customized titanium plates.
The incisions will be closed with continuous mattress resorbable sutures .
Post-operative care:
Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin / Clavulanic acid 625 mg every 8 hours) for 5 days Patients will start analgesics (NSAIDs every 6 hours) for 3 days Mouthwash (Chlorhexidine 0.12%) will be prescribed for 2 more weeks.
Criteria for discontinuing or modifying intervention:
- Difficulty with the use of cutting guides and customized titanium plates.
- Inaccurate translation of the surgical plan.
Strategies to improve adherence to intervention:
Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion.
Concomitant care:
Not needed.
- Follow up & Evaluation:
Post-operative treatment will start immediately postoperative (4 hours). The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
Within the first week postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated.
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics 4-6 weeks postoperatively.
The technique will be evaluated by applying hard tissue parameters to compare the virtual orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image fusion.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Exclusion Criteria:
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: study group
using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.
|
patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Accuracy of the surgical transfer
기간: within first week postoperatively
|
Computer software on pre/postoperative CBCT
|
within first week postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient satisfaction: Visual analog scale (questionnaire)
기간: one week postoperative
|
Visual analog scale (questionnaire)
|
one week postoperative
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Dr.Zain protocol
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
orthognathic surgery에 대한 임상 시험
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Stryker Craniomaxillofacial모집하지 않고 적극적으로하악 골절 | 안면 골절 | 상악 골절 | 악교정 수술 절차미국
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Istanbul Gelisim UniversityIstanbul Aydın University완전한
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Second Affiliated Hospital, School of Medicine,...알려지지 않은