- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07739498
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents (HYRAX_ RME_SME)
Effect of Posterior Disarticulatory Resin Bite Turbos on the Rate of Maxillary Expansion Using HYRAX Expander in Early Adolescent Patients: Randomized Controlled Clinical Trial
연구 개요
상태
상세 설명
This study is conducted as part of a Master's thesis in Orthodontics and aims to investigate the influence of posterior disarticulatory resin bite turbos on the rate of maxillary expansion achieved using a HYRAX expander in early adolescent patients.
The study evaluates whether modifying occlusal contacts can affect skeletal and dental responses during rapid maxillary expansion.
Participants will be monitored clinically throughout the expansion phase.
Participants will be assigned in two groups:
group 1: with posterior bite turbos group 2: without posterior bite turbos
Digital intraoral scans will be taken on a weekly basis to assess changes in maxillary dimensions and to accurately measure the rate and pattern of expansion over time.
These serial digital records provide high-resolution, non-invasive documentation of treatment progress.
CBCT will be taken before the expansion and after retention phase for skeletal and dental measurement .
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Donia Alashker
- 전화번호: 00201557372170
- 이메일: donyaalashker7@mans.edu.eg
연구 장소
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Al Mansurah, 이집트
- 모병
- Orthodontic Department - Faculty of Dentistry Mansoura University
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연락하다:
- Faculty of Dentistry Mansoura University
- 전화번호: 0020502267151
- 이메일: dentfac@mansoura.edu.eg
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 10-14 years.
- Bilateral posterior cross bite.
- Functional lateral cross bite.
- Good general and oral health.
- Normal to decreased vertical height )average FMA 29.7 °± 4.2 °).23
Exclusion Criteria:
- Patients with cleft lip and palate.
- Severe facial asymmetry.
- Anterior open bite.
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Previous orthodontic treatment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: group 1: HYRAX with posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos.
The bite turbos are placed on posterior teeth to achieve occlusal disclusion, aiming to minimize occlusal interference during expansion and potentially enhance skeletal response.
The HYRAX expander is activated according to a standardized protocol throughout the treatment period, with regular follow-up using clinical assessment and weekly intraoral scans.
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Description: Arm 1: Participants in this group receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on the posterior teeth to disclude the occlusion, aiming to reduce occlusal interference and potentially enhance skeletal response during maxillary expansion. The HYRAX appliance is activated according to a standardized expansion protocol. |
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활성 비교기: Group 2 : Expansion without posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance without the use of posterior disarticulatory resin bite turbos.
The appliance is activated according to a standardized expansion protocol similar to the experimental group.
Patients are followed throughout the treatment period with regular clinical assessments and weekly intraoral scans to monitor changes in maxillary dimensions.
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Participants in this group receive a HYRAX rapid maxillary expansion appliance alone without the use of posterior bite turbos.
The appliance is activated following the same standardized expansion protocol as the intervention group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models
기간: Baseline and weekly during the active phase of expansion and after 3 months of retention
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Dental landmarks and measurements on models : d3 :Canine tip. d4: Central fissure of first premolar. d6 :Central fissure of first permanent molar. d_3( inter canine width): Distance between left and right d3. d_4 (inter first premolar width) : Distance between left and right d4. d_6(inter first molar width): Distance between left and right d6. |
Baseline and weekly during the active phase of expansion and after 3 months of retention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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-The effect of the posterior disarticulation on alveolar bone changes by CBCT .
기간: baseline and after three months of retention after complete active expansion
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Skeletal transverse, vertical, nasal width changes and axial inclination of posterior teeth will be evaluated .
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baseline and after three months of retention after complete active expansion
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pain felt by the patient after activating the expansion screw
기간: first two weeks in active phase of expansion
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ain will be assessed using the Visual Analogue Scale (VAS), a 100 mm line with "no pain" at the left end and "the worst unbearable pain" at the right, which corresponds to a pain score between 0 and 10.
All participants will be asked to place a vertical mark indicating the level of pain on the VAS 4 h after each activation for the first two weeks in diary sheet containing the actual size of a 100mm of VAS. 25
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first two weeks in active phase of expansion
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공동 작업자 및 조사자
수사관
- 수석 연구원: Donia Alashker, Faculty of Dentistry Mansoura University
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
기타 연구 ID 번호
- MS.26.02.145
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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