此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System

2026年7月3日更新者：Mohanad Ali Mohammed、University of Baghdad

Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System : A Randomized Clinical Trial

This study is a multi-center, prospective, parallel-group randomized controlled trial designed to compare the orthodontic treatment outcomes of a passive self-ligating bracket system (Damon Ultima) versus a clear aligner system. The primary objective is to evaluate and compare the total orthodontic treatment duration between the two systems in patients with Angle Class I malocclusion and moderate crowding. Secondary objectives include assessing alignment efficiency, patient pain perception at multiple time intervals, dental arch dimension changes, root volume loss percentage, and overall treatment quality using the American Board of Orthodontics Objective Grading System (ABO-OGS).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Participants aged 17-32 years with full permanent dentition, Class I canine and molar relationships, and moderate crowding (4-8 mm) will be randomly assigned in a 1:1 ratio to either the Damon Ultima group or the Clear Aligner group.

For the Damon Ultima group, brackets will be bonded according to a standardized protocol, utilizing a precise archwire sequence from 0.014-inch CuNiTi up to 0.019x0.0275-inch stainless steel wires. For the Clear Aligner group, patients will be treated with a series of thermoformed removable aligners designed via digital software, with instructions to wear them for 22 hours per day, changing aligners every 2 weeks.

Outcome measurements will include total treatment duration in months, pain perception via a 10-cm Visual Analog Scale (VAS), dental arch changes on 3D digital models, and root resorption via Cone-Beam Computed Tomography (CBCT) radiographs.

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Mohanad Ali Mohammed
电话号码：+9647702797532
邮箱：Mohannad.ali1203a@codntal.uobaghda.edu.iq

研究联系人备份

姓名：Harraa Sabbah Abul ameer
电话号码：+9647904546371
邮箱：dr.haraa_sabah@codental.uobaghdad.edu.iq

学习地点

伊拉克
- Al-Rusafa
  - Baghdad、Al-Rusafa、伊拉克、0964
    - University of Baghdad

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人

接受健康志愿者

不

描述

Inclusion Criteria:

Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
Age range between 16-32 years.
Presence of full permanent dentition except the third molars.
Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
Without previous orthodontic treatment/ functional appliances.

Exclusion Criteria:

Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
Patient with class Ⅱ , Ⅲ malocclusion.
Patient with external or internal root resorption.
Patients with poor oral hygiene or active periodontal disease.
90o or more degree of tooth rotation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Self ligating bracket (Damon Ultima) Patient will be treated with self ligating bracket (Damon Ultima) until dental levelling alignment , crowding resolved and case will be finished	设备：self ligating bracket Teeth will be bonded with Damon Ultima® bracket system by the same protocol of bonding for all patients with the same bonding materials, time and curing apparatus by highly filled light-cure adhesive (Enlight, Ormco Corp., Glendora, California, USA). Archwire sequence will be: 0.014-inch CuNiTi, 0.018-inch CuNiTi, 0.014×0.0275-inch CuNiTi, 0.018×0.0275-inch CuNiTi archwires and 0.019×0.0275-inch stainless steel Ultima finishing archwires if needed. Appointment intervals will be 6-8 weeks for treatment mechanics, including use of inter-arch elastics, bite raiser, and finishing procedures will be standardized. All patients will receive oral hygiene instructions at each visit. In case of bracket failure, brackets will be rebonded using the same system within 24 hours, otherwise the case would be considered as dropout.
实验性的：Clear aligner system Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished	设备：Clear aligner a series of invisible thermoformed removable aligners after designed by software and delivered to patients after the digital scanning of the initial models. A series of nearly invisible appliances to incrementally move the teeth from their crowded initial position to their final straightened position, these subjects will instructed to wear each aligner 22 hours a day, 7 days a week . The anterior teeth will be reduce at each interproximal location by means of diamond-coated finishing strips used for interproximal reduction , in case of debond attachment should be bonded within 24 hours.

参与者组/臂

干预/治疗

实验性的：Self ligating bracket (Damon Ultima)

Patient will be treated with self ligating bracket (Damon Ultima) until dental levelling alignment , crowding resolved and case will be finished

设备：self ligating bracket

Teeth will be bonded with Damon Ultima® bracket system by the same protocol of bonding for all patients with the same bonding materials, time and curing apparatus by highly filled light-cure adhesive (Enlight, Ormco Corp., Glendora, California, USA). Archwire sequence will be: 0.014-inch CuNiTi, 0.018-inch CuNiTi, 0.014×0.0275-inch CuNiTi, 0.018×0.0275-inch CuNiTi archwires and 0.019×0.0275-inch stainless steel Ultima finishing archwires if needed.

Appointment intervals will be 6-8 weeks for treatment mechanics, including use of inter-arch elastics, bite raiser, and finishing procedures will be standardized. All patients will receive oral hygiene instructions at each visit. In case of bracket failure, brackets will be rebonded using the same system within 24 hours, otherwise the case would be considered as dropout.

实验性的：Clear aligner system

Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished

设备：Clear aligner

a series of invisible thermoformed removable aligners after designed by software and delivered to patients after the digital scanning of the initial models.

A series of nearly invisible appliances to incrementally move the teeth from their crowded initial position to their final straightened position, these subjects will instructed to wear each aligner 22 hours a day, 7 days a week . The anterior teeth will be reduce at each interproximal location by means of diamond-coated finishing strips used for interproximal reduction , in case of debond attachment should be bonded within 24 hours.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Primary Objectives : Total Treatment Duration. 大体时间：From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).	The total time required to complete the orthodontic treatment from the day of appliance bonding/delivery to the day of debonding/treatment completion.	From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).

次要结果测量

结果测量	措施说明	大体时间
Patient Pain Perception. 大体时间："Baseline (Day 1), and at 6 hours, 24 hours, 3 days, and 7 days following the initial appliance insertion and after each subsequent archwire activation or aligner change throughout the active treatment phase, up to 14 months."	Changes in pain levels scored by patients using a Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "severe, unbearable pain". Units on a scale (0-10).	"Baseline (Day 1), and at 6 hours, 24 hours, 3 days, and 7 days following the initial appliance insertion and after each subsequent archwire activation or aligner change throughout the active treatment phase, up to 14 months."
Dental Arch Alignment Efficiency 大体时间：Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.	Assessment of dental crowding reduction measured on 3D digital models using Little's Irregularity Index (LII) Unit of Measure: Millimeters (mm).	Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.
Changes in Dental Arch Dimensions 大体时间：Baseline (Day 1) and through study completion, an average of 14 months	Measurement of dental arch length, arch perimeter, and transverse widths (inter-canine, inter-premolar, and inter-molar widths) on 3D digital models. Unit of Measure: Millimeters (mm).	Baseline (Day 1) and through study completion, an average of 14 months
Root Volume Loss Percentage. 大体时间：Baseline (Day 1) and through study completion, an average of 14 months	Evaluation of external apical root resorption and volume loss percentage of the teeth calculated via Cone-Beam Computed Tomography (CBCT). Unit of Measure: Percentage (%).	Baseline (Day 1) and through study completion, an average of 14 months
Objective Grading System Score. 大体时间：Through study completion, an average of 14 months	Evaluation of the final orthodontic treatment outcome quality using the American Board of Orthodontics Objective Grading System (ABO-OGS) on digital models. Unit of Measure: Points/Score.	Through study completion, an average of 14 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Baghdad

调查人员

首席研究员：Mohanad Ali Mohammed、University of Baghdad

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月15日

初级完成 (估计的)

2027年11月20日

研究完成 (估计的)

2028年8月20日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月3日

最后验证

2026年7月1日

Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System