NCT02549950Unknown不适用
Efficiency and Efficacy of Peizo-Coticision in Reducing Orthodontic Treatment Time: Randomized Clinical Trial
AL Yousef1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of orthodontic canine movement
研究概览
简要总结
The purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time.
详细描述
1 Aim of the study- Part I:
This prospective controlled clinical trial (CCT), Split Mouth Design is conducted to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of canine teeth in class II div 1 subjects.
Specific aim- Part I:
A- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved canines
B- To compare length of treatment of both approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study Subjects for Part I and Part II:
- •Voluntary participation of patients only
- •Able to follow instruction, able to understand the consent form and sign it.
- •Adult Female and Male Saudi patients 15-35 y.o
- •Subjects who are none smokers
- •Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
- •Subjects with good periodontal and gingival health: Gingival Index GI≤ 1
- •Subjects with a none gummy smile,
- •Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings
- •Subjects without root anomalies
- •Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion
排除标准
- •Subjects younger than 15 y.o
- •Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
- •Subjects who are medically classified as ASA-II, III
- •Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
- •Subjects who are pregnant
- •Subjects who are smokers
- •Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma
- •Subjects with unhealthy or compromised periodontium
- •Subjects with a gummy smile
- •Subjects with inadequately treated endodontic and dental fillings problems
- •Subjects with previous root resorption or dental developmental anomalies
- •Subjects who had previous orthodontic treatment
- •Subjects with TMJ signs and symptoms; Mandibular functional shift
- •Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm
- •Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.
- •Subjects will be excluded if any of mini-screws failed during treatment
- •Subjects who become medically unfit during course of trial
研究组 & 干预措施
Conventional OrthodonticTreatment
Active Comparator
Conventional orthodontic mechanics: canine and incisor retraction
干预措施: Conventional Orthodontic Mechanics (Procedure)
Accelerated Tooth Movement
Experimental
Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction
干预措施: Peizocorticision (Procedure)
结局指标
主要结局
Rate of orthodontic canine movement
时间窗: 4-6 months
次要结局
- Rate of orthodontic Incisor Retraction(4-6 months)
研究者
AL Yousef
Sally K Al Yousef BDS; AEGD; GPR; MSc-Orthodontics
King Abdullah International Medical Research Center
研究点 (1)
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