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临床试验/NCT04043013
NCT04043013已完成不适用

Influence of Four Different Orthodontic Bracket Prescriptions in Total Posterior Arch Width and Torque Expression

University of Valencia0 个研究点目标入组 76 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
主要终点
Change of posterior torque from the initial occlusion to the final occlusion at the end of the orthodontic treatment.

研究概览

简要总结

The study compares torque and arch width changes between four different orthodontic bracket prescriptions and determine whether changes in dental torque are correlated to changes in arch width at the end of orthodontic treatment.

From an initial sample of 250 patients who sought treatment at the Department of Orthodontics (University of Valencia, Spain), a subsample of 76 patients (31 men and 45 women) were selected to meet inclusion criteria.

The sample was randomly allocated into four groups according to four different orthodontic bracket prescriptions: Prescription A (n=22): Mini-Taurus® (Rocky Mountain©); Prescription B (n=17): Smart Clip® SL3 High Torque (3M Unitek©); Prescription C (n=18): Tip-Edge Plus® (TP Orthodontics©); Prescription D (n=19): Victory® (3M Unitek©).

Initial (T0) and final (T1) plaster and digital study models were available for all patients. Measurements were taken from frontal and occlusal images of the models by a single experienced operator.

详细描述

Subjects Seventy-six patients (31 men and 45 women) were recruited to participate in the clinical study and who fulfilled the inclusion and exclusion criteria. The inclusion criteria were: Presence of permanent dentition from the first permanent molar, from one side to the other, absence of anomalies in number, size and dental shape, no pre-treatment transversal discrepancies, equivalency in pre-treatment vertical relationships, good quality of study models, no medical contra-indications to the use of fixed appliances and good standard of oral hygiene.

The exclusion criteria were: Presence of oral habits. need to use of two band expansive appliances through the treatment, need of an orthodontic treatment with extractions or requiring orthognathic surgery as a part of their treatment. Subject age and gender were not taken as exclusion criteria, as these variables were not expected to influence the research outcomes.

Sample size calculation A pre-study sample size calculation was performed; power analysis showed that a sample size of at least 64 patients would provide an 80% probability of detecting a medium effect (f=0.2) associated with the interaction term, using an ANOVA model at a confidence level of 95% and assuming a correlation among repeated measurements of 0.5.

Study design: Orthodontic prescription techniques Subjects were chosen randomly and prospectively. Using sealed envelopes with the letters A to D, which corresponded to the 4 treatment groups, patients were parallelly randomly allocated according to the orthodontic bracket prescription of each particular technique so that patients each received either Prescription A (n=22): Mini-Taurus (Rocky Mountain); Prescription B (n=17): Smart Clip SL3 High Torque (3M Unitek); Prescription C (n=18): Tip-Edge Plus (TP Orthodontics); and Prescription D (n=19): Victory (3M Unitek). All underwent standard orthodontic treatments with good occlusal results.

Blinding Once the patient had been randomly allocated to one group or another, it was not possible to blind either the patient or the operator to the bracket type.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presence of permanent dentition from the first permanent molar, from one side to the other.
  • •Absence of anomalies in number, size and dental shape
  • •No pre-treatment transversal discrepancies
  • •Equivalency in pre-treatment vertical relationships
  • •Good quality of study models
  • •No medical contra-indications to the use of fixed appliances
  • •Good standard of oral hygiene

排除标准

  • •Presence of oral habits
  • •Need to use of two band expansive appliances through the treatment
  • •Need of an orthodontic treatment with extractions
  • •Requiring orthognathic surgery as a part of their treatment

研究组 & 干预措施

Mini-Taurus® (Rocky Mountain©) Brackets

Active Comparator

Brackets Mini-Taurus® (Rocky Mountain©) with:

ORTHODONTIC BRACKET PRESCRIPTION Canines 0º First Premolar 0º Second Premolar 0º First Molar 0º

干预措施: Smart Clip® SL3 High Torque (3M Unitek©) (Device)

Mini-Taurus® (Rocky Mountain©) Brackets

Active Comparator

Brackets Mini-Taurus® (Rocky Mountain©) with:

ORTHODONTIC BRACKET PRESCRIPTION Canines 0º First Premolar 0º Second Premolar 0º First Molar 0º

干预措施: Tip-Edge Plus® (TP Orthodontics©) (Device)

Mini-Taurus® (Rocky Mountain©) Brackets

Active Comparator

Brackets Mini-Taurus® (Rocky Mountain©) with:

ORTHODONTIC BRACKET PRESCRIPTION Canines 0º First Premolar 0º Second Premolar 0º First Molar 0º

干预措施: Victory® (3M Unitek©) (Device)

Smart Clip® SL3 High Torque (3M Unitek©)

Active Comparator

Brackets Smart Clip® SL3 High Torque (3M Unitek©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines +6º First Premolar -4º Second Premolar -4º First Molar -14º

干预措施: Victory® (3M Unitek©) (Device)

Smart Clip® SL3 High Torque (3M Unitek©)

Active Comparator

Brackets Smart Clip® SL3 High Torque (3M Unitek©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines +6º First Premolar -4º Second Premolar -4º First Molar -14º

干预措施: Mini-Taurus® (Rocky Mountain©) Brackets (Device)

Smart Clip® SL3 High Torque (3M Unitek©)

Active Comparator

Brackets Smart Clip® SL3 High Torque (3M Unitek©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines +6º First Premolar -4º Second Premolar -4º First Molar -14º

干预措施: Tip-Edge Plus® (TP Orthodontics©) (Device)

Tip-Edge Plus® (TP Orthodontics©)

Active Comparator

Brackets Tip-Edge Plus® (TP Orthodontics©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines -4º First Premolar -7º Second Premolar -7º First Molar 0º -14º -11º -14º

干预措施: Mini-Taurus® (Rocky Mountain©) Brackets (Device)

Tip-Edge Plus® (TP Orthodontics©)

Active Comparator

Brackets Tip-Edge Plus® (TP Orthodontics©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines -4º First Premolar -7º Second Premolar -7º First Molar 0º -14º -11º -14º

干预措施: Smart Clip® SL3 High Torque (3M Unitek©) (Device)

Tip-Edge Plus® (TP Orthodontics©)

Active Comparator

Brackets Tip-Edge Plus® (TP Orthodontics©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines -4º First Premolar -7º Second Premolar -7º First Molar 0º -14º -11º -14º

干预措施: Victory® (3M Unitek©) (Device)

Victory® (3M Unitek©)

Active Comparator

Brackets Victory® (3M Unitek©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines 0º First Premolar -7º Second Premolar -7º First Molar -14º

干预措施: Mini-Taurus® (Rocky Mountain©) Brackets (Device)

Victory® (3M Unitek©)

Active Comparator

Brackets Victory® (3M Unitek©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines 0º First Premolar -7º Second Premolar -7º First Molar -14º

干预措施: Smart Clip® SL3 High Torque (3M Unitek©) (Device)

Victory® (3M Unitek©)

Active Comparator

Brackets Victory® (3M Unitek©) with:

ORTHODONTIC BRACKET PRESCRIPTION

Canines 0º First Premolar -7º Second Premolar -7º First Molar -14º

干预措施: Tip-Edge Plus® (TP Orthodontics©) (Device)

结局指标

主要结局

Change of posterior torque from the initial occlusion to the final occlusion at the end of the orthodontic treatment.

时间窗: Measurement 1: At the begining of orthodontic treatment. Measurement 2: through orthodontic treatment completion, an average of 18 months

Degrees

Change of arch width from the initial occlusion to the final occlusion at the

时间窗: Measurement 1: At the beginning of orthodontic treatment. Measurement 2: through orthodontic treatment completion, an average of 18 months

Millimeters

次要结局

未报告次要终点

研究者

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

Jose Luis Gandía-Franco

Director

University of Valencia

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