SmartWire Multiforce Archwire Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Alignment of dental arches
研究概览
简要总结
The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.
详细描述
This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used.
Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment.
Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects.
Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult >14yrs of age
- •Amenable to treatment with metal brackets
- •Crowding of 3-8mm in one or both arches (non-extraction treatment)
- •Overbite >3mm
- •Read and speak English without a translator
- •Individuals in good general health at the discretion of the investigator(s)
排除标准
- •Medical/Dental History (Hx):
- •Documented metabolic disorder(s)
- •Nickel allergy
- •Bisphosphonate treatment
- •Amelogenesis, dentinogenesis or osteogenesis imperfect
- •Active caries or periodontal disease
- •Root resorption (moderate to severe)
- •Patients who are pregnant or breast feeding or plan to be pregnant during the study
研究组 & 干预措施
Multiforce
Variable modulus version of a current orthodontic archwire
干预措施: Orthodontic archwire (Device)
CuNiTi A
.016" current orthodontic archwire
干预措施: Orthodontic archwire (Device)
CuNiTi B
0.014" and 0.018" current orthodontic archwire sequence
干预措施: Orthodontic archwire (Device)
结局指标
主要结局
Alignment of dental arches
时间窗: Initial six months of treatment
Tooth alignment rate in response to force from archwire measured in mm on dental models
次要结局
- Expression of external apical root resorption (EARR)(Initial six months of treatment)
- Leveling of dental arches(Initial six months of treatment)