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临床试验/NCT04591080
NCT04591080已完成不适用

A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年9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
12
试验地点
2
主要终点
Total Amount of Canine Retraction

研究概览

简要总结

When there is space present between our teeth orthodontically we have the ability to close them through many methods. Using braces as our treatment modality this study will be investigating how efficient a new orthodontic wire is in closing tooth space. This new material is trade-named GUMMETAL and claims to have many benefits to treating patients orthodontically. We will be exploring its efficiency in space closure compared to an industry standard (stainless steel). We predict that the stainless-steel orthodontic wire will be more efficient at space closure than the new GUMMETAL wires.

详细描述

This will be a randomized pilot split-mouth clinical trial of patients with spaces ≥ 3mm distal to the maxillary canines in need of closure through sliding mechanics. The sample consists of adolescent patients regardless of Angle's molar malocclusion who are receiving comprehensive full fixed appliance orthodontic treatment. Preformed conjoint archwires half being GUMMETAL and the other half SS, will be utilized. Each patient will have one side of the maxilla randomly allocated into the SS or GUMMETAL treatment group. The study will follow a split-mouth design to reduce the confounding variables from patient to patient on space closure mechanics. The maxillary arch in each subject will be randomized into a SS side or GM side using a random number generator. Spaces will be measured at; T0 is initial records, T1 is initiation of space closure, T2 will be 4 weeks after the initiation of space closure, T3 is another 4 weeks of space closure evaluation and T4 will be the final evaluation of space closure after 4 weeks from T3, via 3D intraoral scans of maxillary arches. Space measurement and calculations will utilize 3Shape software to measure the distance of canine movement based off the distal surface. Sliding mechanics will be activated through NiTi coil springs from the maxillary canines to the maxillary molars. The force will be standardized to 150 gms and will be measured each visit. The same provider will activate the NiTi coil spring for retraction, along with data collection. Superimposition of scans will be utilized to assess outcome measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The participants will not know which intervention is on which side of their mouth, but will know that they are getting both types of interventions simultaneously, given the split-mouth design of the study.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Full permanent dentition (except third molars)
  • Good general and oral health
  • Bilateral spaces 3 >/= mm distal to the maxillary canines
  • Normal and hypodivergent growth pattern
  • Any dental malocclusion
  • Good Oral Hygiene

排除标准

  • Systemic diseases or syndrome
  • Abnormalities in teeth size and/or shape
  • Previous orthodontic treatment
  • Anti-inflammatory medication
  • Craniofacial anomalies
  • Hyperdivergent growth pattern
  • Periodontal disease / attachment loss exceeding 25% of root length
  • Significant pre or in-treatment root resorption

结局指标

主要结局

Total Amount of Canine Retraction

时间窗: 12 weeks

Canine movement measured at distal marginal ridge

次要结局

  • 3-Dimensional Control of Canine Movement Assessment(12 weeks)
  • Rate of Canine Retraction Per Month(12 weeks)

研究者

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

Lubomyr Ravlyk

Orthodontic Resident

State University of New York at Buffalo

研究点 (2)

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