- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03149016
The Use of Corticotomy for Upper Incisors Retraction
Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial
연구 개요
상세 설명
In the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life .
So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Damascus, 시리아 아랍 공화국, DM20AM18
- Department of Orthodontics, University of Damascus Dental School
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
- Overjet less than 10 mm
- Normal or increased growth pattern (Diagnosed by Y-axis angle)
- Mild to moderate crowding (Less than 3 mm)
- After canines retraction , at least 3 mm space should be available distal the lateral incisors
- Midline deviation shouldn't be more than 3 mm
Exclusion Criteria:
- Medically contraindicated patients to oral surgery .
- Existence of general health issue that affect orthodontic teeth movement
- Previous orthodontic treatment
- Mixed dentition
- Hypodontia (Except third molars)
- Bad oral hygiene
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: Corticotomy-assisted Retraction
Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction
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Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
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간섭 없음: Conventional Retraction
Conventional retraction will be used in this group of patients by sliding mechanisms
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of retraction
기간: This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
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The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.
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This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.
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Time required for retraction
기간: This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
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The time required from the beginning of incisors' retraction till the the completion of this procedure.
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This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in the axial inclination of upper incisors
기간: A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
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the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
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A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo
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Anchorage loss
기간: This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
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the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae .
These measurements are made on plaster study models.
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This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group
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Root resorption
기간: An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
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This variable is related to the amount of incisor root resorption after treatment in both groups.
This is measured on a panoramic image.
The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction.
Two radiogrpahs are needed.
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An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ghaith Al Imam, DDS, MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria
간행물 및 유용한 링크
일반 간행물
- Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.
- Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.
- Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1880-9. doi: 10.1016/j.joms.2014.05.003. Epub 2014 May 14.
- Choo H, Heo HA, Yoon HJ, Chung KR, Kim SH. Treatment outcome analysis of speedy surgical orthodontics for adults with maxillary protrusion. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):e251-62. doi: 10.1016/j.ajodo.2011.06.029.
- Chung KR, Kim SH, Lee BS. Speedy surgical-orthodontic treatment with temporary anchorage devices as an alternative to orthognathic surgery. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):787-98. doi: 10.1016/j.ajodo.2007.03.036.
- Dincer M, Gulsen A, Turk T. The retraction of upper incisors with the PG retraction system. Eur J Orthod. 2000 Feb;22(1):33-41. doi: 10.1093/ejo/22.1.33.
- KOLE H. Surgical operations on the alveolar ridge to correct occlusal abnormalities. Oral Surg Oral Med Oral Pathol. 1959 May;12(5):515-29 concl. doi: 10.1016/0030-4220(59)90153-7. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 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. .
2급 부정교합 1급에 대한 임상 시험
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Postgraduate Institute of Dental Sciences Rohtak모병
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Damascus University완전한
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Jordan University of Science and TechnologyUniversity of Edinburgh; University of Sydney완전한
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Bezmialem Vakif UniversityPEBS DENTAL CLINIC모병
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University of Jordan모집하지 않고 적극적으로
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Ahmed Reda Abd EL Rahman아직 모집하지 않음복합 수복물 | 3D 프린팅 | 구치부의 근위 공동 | Class II 병변 | 대량 채우기
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Chesterfield and North Derbyshire Royal Hospital완전한
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Jordan University of Science and Technology완전한
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Aslam AlkadhimiUniversity of Dublin, Trinity College; Health Service Executive, Ireland; Dublin Dental University...아직 모집하지 않음성장 | 해체 | 2급 부정교합 | 클래스 II 성장 수정 | 오버제트 | 구강 건강 관련 삶의 질 | Class II 협측 분절 관계 | 2급 부정교합 1급아일랜드
Corticotomy-assisted Retraction에 대한 임상 시험
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Cathbot (Shanghai) Robot Co., LtdPeople's Hospital of Xinjiang Uygur Autonomous Region; Karamay Central Hospital of Xinjiang 그리고 다른 협력자들초대로 등록
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Damascus University완전한
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Kun SunBill and Melinda Gates Foundation완전한선천성 심장병(CHD) | 임상 평가를 위한 청진 | 무작위 대조 시험 | 스크리닝 도구 | 인공지능중국
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Clear Guide MedicalThe Cooper Health System완전한
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Oslo University HospitalThe Research Council of Norway완전한림프종 | 백혈병 | 암 | 줄기세포 이식
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Harvard Medical School (HMS and HSDM)Massachusetts General Hospital; National Taiwan University Hospital; Brigham and Women's... 그리고 다른 협력자들완전한급성 골수성 백혈병(AML) | 급성 전골수구성 백혈병(APL)미국
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NYU Langone Health종료됨