- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07708363
Bracket Positioning Techniques and Quality of Orthodontic Finishing
Comparison of Three Bracket Positioning Techniques (Smile Arc Protection, Smile Arc and Marginal Ridge Approach, and McLaughlin-Bennett-Trevisi) on the Quality of Orthodontic Finishing, Mini-Esthetics, and Anterior Tooth Tip and Torque: A Three-Arm Randomized Clinical Trial
연구 개요
상태
상세 설명
Bracket positioning is one of the most influential operator-dependent factors affecting the quality of orthodontic finishing and the resulting smile esthetics. Three contemporary positioning philosophies are compared in this trial.
Design. Eligible participants are randomly allocated 1:1:1 to one of three parallel arms. Allocation is generated with an online randomizer, concealed in sequentially opaque sealed envelopes held by a co-supervisor, and revealed only on the day of intervention. Outcome assessors are blinded; operator blinding is not feasible.
Intervention. All arms receive a fully digital indirect-bonding workflow (intraoral scanning, virtual bracket placement in 3Shape Ortho-Analyzer, 3D-printed casts, vacuum-formed transfer trays) using a 0.018-inch MBT prescription, and an identical arch wire sequence ending in a 0.017 in × 0.025 in stainless steel wire maintained for three months. The arms differ only in the vertical/angular bracket-positioning rule applied (SAP, SAMRA, or MBT chart).
Assessment. Records are captured before bonding (T₀) and at the end of levelling and alignment (T₁). The ABO-OGS is scored on 3D-printed casts and the panoramic radiograph; tip and torque are measured on dentoalveolar CBCT; mini-esthetic parameters are measured on standardized frontal posed-smile photographs calibrated in Adobe Photoshop.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo Governorate
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New Cairo, Cairo Governorate, 이집트, 11835
- Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Males and females aged 14-25 years with a full permanent dentition.
- Mild to moderate crowding requiring non-extraction orthodontic treatment (2-6 mm per Graber's classification).
- Angle Class I malocclusion.
- Normal skeletal vertical dimension (SN-MP angle 32° ± 5°).
Exclusion Criteria:
1. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
2. Impacted, extracted, or missing permanent teeth (except third molars). 3. Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
4. History of previous orthodontic treatment. 5. Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.
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: Group SAP
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
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Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
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실험적: Group SAMRA
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
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Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
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활성 비교기: Group MBT (Control)
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
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Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
기간: At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
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Total ABO-OGS score obtained on the Cast-Radiographic Evaluation (CRE) form.
Seven parameters - alignment/rotations, marginal ridges, buccolingual inclination, occlusal contacts, occlusal relationships, overjet, and interproximal contacts - are scored on 3D-printed casts with the ABO measuring gauge; root angulation is scored on the panoramic radiograph.
Point deductions are summed to give the total score (a lower total indicates better finishing).
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At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anterior crown angulation (tip) - CBCT
기간: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in mesiodistal crown angulation (tip) of the anterior teeth, measured in degrees on dentoalveolar CBCT using defined landmarks and reference planes.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Anterior crown inclination (torque) - CBCT
기간: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in labiolingual crown inclination (torque) of the anterior teeth, measured in degrees on dentoalveolar CBCT.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Maxillary gingival display
기간: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in maxillary gingival display - the vertical distance (mm) between the inferior border of the upper lip and the gingival zenith of each maxillary anterior tooth (central incisor, lateral incisor, canine, both sides) on standardized posed-smile frontal photographs, measured in Adobe Photoshop after calibration against a metric ruler.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Maxillary incisal display
기간: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in maxillary incisal display - the vertical amount (mm) of maxillary incisor crown visible relative to the upper lip during a posed smile, on standardized photographs.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Buccal corridor width
기간: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in buccal corridor (lateral negative space) - the linear distance (mm) between the most posterior visible maxillary tooth and the corner of the mouth during posed smile, measured on each side and averaged.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Smile arc category
기간: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Smile arc classified as consonant, flat, or reversed based on the relationship between the curvature of the maxillary incisal/canine/premolar edges and the curvature of the lower lip during posed smile.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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공동 작업자 및 조사자
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 연구와 관련된 용어
키워드
기타 연구 ID 번호
- FUE.REC(42)/10-2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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