Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
研究概览
简要总结
The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. In addition, the subjects in the piezotome-corticision orthodontics group will experience a different level of pain, comfort, and satisfaction as opposed to the conventional orthodontics group.
详细描述
This study will specifically try:
- To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics.
- To investigate the rate of alignment of mandibular anterior teeth at different time points until complete alignment is achieved using dental casts taken at every visit.
- To compare subject's perception of pain, comfort and satisfaction between the piezotome-corticision assisted and conventional orthodontics using two questionnaires.
Eligibility criteria includes:
- Adult patients 18 or older
- Single arch or double arch treatment
- Non-extraction treatment in the mandibular arch
- Presence of full complement dentition from first molar to first molar
- No spaces in the mandibular arch
- Mandibular anterior irregularity index greater than 5
- Patient with healthy periodontium and attachment loss of up to 2mm
- The amount of crowding should allow for bracket placement
- No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Exclusion criteria includes:
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
- Double (Investigator, 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
- 是
入选标准
- •Adult patients 18 or older
- •Single arch or double arch treatment
- •Non-extraction treatment in the mandibular arch
- •Presence of full complement dentition from first molar to first molar
- •No spaces in the mandibular arch
- •Mandibular anterior irregularity index greater than 5
- •Patient with healthy periodontium and attachment loss of up to 2mm
- •The amount of crowding should allow for bracket placement
- •No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
排除标准
- •Failure to provide oral and written consent to participation
- •Medical problems that affect tooth movement (Refer to Appendix I)
- •Presence of primary teeth in the mandibular anterior area
- •Missing permanent mandibular anterior teeth
- •Inability to place brackets in the anterior mandibular teeth
- •Breakage of any of the mandibular anterior brackets that have not been replaced within a week
研究组 & 干预措施
Orthodontics no piezocision
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
干预措施: Orthodontics (Device)
Orthodontics with piezotome corticision
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
干预措施: Piezotome-Corticision (Procedure)
Orthodontics with piezotome corticision
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
干预措施: Orthodontics (Device)
结局指标
主要结局
Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
时间窗: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.
次要结局
- Questionnaire on Easiness and Satisfaction With the Procedure(4-5 weeks after first wire placement)
- Questionnaire Involving Pain Management and Satisfaction With the Procedure(4-5 weeks after first wire placement)
- Questionnaires Involving Pain Level(Immediate to 1 week after wire placement (T0-T3))
研究者
Flavio Uribe
Associate Professor
UConn Health