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临床试验/NCT07708363
NCT07708363已完成不适用

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

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score

研究概览

简要总结

This three-arm randomized clinical trial compares three orthodontic bracket positioning techniques - Smile Arc Protection (SAP), Smile Arc and Marginal Ridge Approach (SAMRA), and the McLaughlin-Bennett-Trevisi (MBT) bracket placement chart (control) - in young patients with Angle Class I malocclusion and mild-to-moderate crowding treated non-extraction. The primary aim is to determine which technique yields the highest quality of orthodontic finishing, measured with the American Board of Orthodontics Objective Grading System (ABO-OGS). Secondary aims compare anterior tooth tip and torque (assessed by CBCT) and mini-esthetic smile parameters (gingival display, incisal display, buccal corridor, and smile arc, assessed on standardized posed-smile photographs) among the three techniques.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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°).

排除标准

  • 1. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
  • 2. Impacted, extracted, or missing permanent teeth (except third molars).
  • Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
  • 4. History of previous orthodontic treatment.
  • Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.

结局指标

主要结局

Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score

时间窗: 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.

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).

次要结局

  • Anterior crown angulation (tip) - CBCT(Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding)
  • Anterior crown inclination (torque) - CBCT(Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding)
  • Maxillary gingival display(Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding)
  • Maxillary incisal display(Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding)
  • Buccal corridor width(Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding)
  • Smile arc category(Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hager Mansour Abdelbaseer Zoghby

Dr.

Future University in Egypt

研究点 (1)

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