3D Printed Reverse Twin Block for Class III Malocclusion (3DRTB)
Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical Trial
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.
primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Linda Basim, PhD
- 전화번호: +9647812867005
- 이메일: landa.hadi2403@codental.uobaghdad.edu.iq
연구 장소
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Baghdad, 이라크
- 모병
- Collage of Dentistry, University of Baghdad
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
- Presence of permanent first molar with lower anterior teeth to retain the appliance.
Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.
b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2.
- Prescence of unilateral or bilateral posterior crossbite.
- Mild to moderate anterior crowding.
- Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
Exclusion Criteria:
- Patients with cleft lip and palate and/or craniofacial anomalies.
- History of previous orthopedic and/or orthodontic treatment.
- Presence of uncontrolled systemic disease or medically compromised status.
- Uncooperative patient/parents.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 3D printed Reverse Twin Block appliance
patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin.
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a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
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활성 비교기: Conventional Reverse Twin Block appliance
patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin.
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a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in sagittal relation using lateral cephalometric radiograph.
기간: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
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By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees.
2. SNB angle in degrees.
3. ANB angle in degrees.
4. Wits appraisal in degrees. 5. SN-Pog angle
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T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Transverse relationship by Study model
기간: T0 baseline records T1 after 3 months T2 after 6 months
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This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2.
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T0 baseline records T1 after 3 months T2 after 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oral hygiene index-children (OHI-C) will be measured
기간: T0 baseline record T1 after 3 months T2 after 6 months
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The six index teeth that will be included:
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T0 baseline record T1 after 3 months T2 after 6 months
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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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1213426
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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