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临床试验/NCT03363620
NCT03363620已完成3 期

Comparison of Arch Expansion Changes Between Passive Self-ligating and Conventional Brackets With Broad Arches After Alignment and Levelling With the Same Arch Protocol: A Randomized Controlled Trial

CES University0 个研究点目标入组 54 人开始时间: 2015年1月20日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
54
主要终点
transverse development of the arches

研究概览

简要总结

The purpose of this randomized controlled clinical trial was to compare the transverse development of the arches and the incisor inclination comparing two different ligating systems (SL vs CL) with the same arch form protocol (Damon arch form) and the same disarticulation protocols after the alignment and leveling period of non-extraction patients.

详细描述

Materials and Methods

Fifty-four subjects were randomly with an electronic randomization program allocated to treatment with either a self-ligating bracket system (Damon Q-slot 0.022", Ormco Corp,) or a conventional bracket system (Orthos-slot 0.022", Ormco Corp). All patients were treated following the same protocol and arch wire sequence: 0.014-inch, 0.018-inch and 0.014x0.025-inch Damon copper nickel-titanium arch wires (Cu-NiTi; Ormco). Lateral cephalograms and study models, taken at prior to treatment (T0) and after alignment and levelling (T1), were used to compare the amount of arch expansion and incisor angulation changes that took place. In the analysis of results in a single observer analyzes the data blindly without knowing which group the patients belonged. Results: Models and cephalograms of the patients and both stages(T0-T1) were measured at the data were analyzed in STATA S.E. Treatment produce statistically significant increases in transverse arch dimensions especially in premolars maxillary (2.8-4.3mm) and mandibullary (2.0-4.2mm) of both group. The expansion in the maxillary arch was similar for both groups, but in the mandibular arch was greater in the self ligation group in about 2 mm more. Conclusions: The treatment with self ligation brackets produced more expansion in the mandibular arch than the conventional ligation brackets when used the same arch Damon protocols.

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

性别
All
接受健康志愿者
否

入选标准

  • •ANB angle between 0º- 5º
  • •Systemically and periodontally healthy subjects not taking any medications.
  • •Maxillary and/or mandibular irregularity index (canine-to-canine) between mild to moderate
  • •A non-extraction treatment approach.
  • •Permanent dentition with second molars erupted or in a functional eruptive phase.

排除标准

  • •Systemically and periodontally compromise subjects and taking any medications. (2 ) subjects who did not want participate in the investigation

研究组 & 干预措施

self ligation brackets damon ormco®

Experimental

the self ligation bracket (damon system) in the orthodontic treatment, was used in the experimental group with the recommended protocol damon arches sequence.

干预措施: Orthodontic Brackets (Device)

conventional brackets orthos ormco®

Active Comparator

the conventional bracket (orthos system) in the orthodontic treatment, was used in the active comparator group with the recommended protocol damon arches sequence as used in the experimental group.

干预措施: Orthodontic Brackets (Device)

结局指标

主要结局

transverse development of the arches

时间窗: 2 years

The maxillary and mandibular widths were measured between the cusp tips of the canines, the buccal cusp tips of the first and second premolars and the mesio-buccal cusp tips of the first molars . They were measured using a digital caliper (Starrett 799A-6/150 Digital Caliper, Athol, Massachusetts, USA) positioned parallel to the occlusal plane.

次要结局

  • incisor inclination(2 years)

研究者

发起方
CES University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANGELA MARIA SIERRA ANGEL

ORTHODONTIST

CES University

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