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"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction

2021年2月4日更新者：Postgraduate Institute of Dental Sciences Rohtak

"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction: A Split Mouth Randomized Clinical Trial"

Acceleration of orthodontic tooth movement persuades tremendous rise in the interest of adolescents and aduts, as it not only shortens the treatment duration but also lessens the incidence of white spot lesions, root resorption, periodontal and other soft tissue problems. Minimal invasive techniques i.e.both piezocision and micro-osteoperforations had promising results in accelerating tooth movement. Therefore current study will provide evidence for better minimal invasive technique in terms of reducing treatment time and patient comfort.

研究概览

地位

未知

条件

Angle Class II, Division 1 Malocclusion

干预/治疗

详细说明

Patients with Angle's Class II division 1 malocclusion meeting selection criteria and are indicated for maxillary first premolar extraction, patients will be referred for extraction of the maxillary first premolars , treatment will be initiated by bonding preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, leveling and alignment will be done in all subjects, after insertion of 0.019"× 0.025" stainless steel arch wire, alginate impression and periapical radiograph of canine and first molar region will be taken(Before the initiation of canine retraction), randomisation and allocation of two sides of maxillary arch i.e. right and left will be done and active interventions(piezocision and micro-osteoperforations) for each side will be done, immediately maxillary canine retraction will be started with mini-implant and closed NiTi coil spring, patient will be asked to fill pain and discomfort assessment card immediately after initiation of canine retraction., subsequent impressions records will be taken at 4th, 8th, 12th and 16th weeks for measuring rate of maxillary canine retraction, data collection and interpretation of results, further pain assessment cards will be filled after 24 hours, on 7th day and 28th day

研究类型

介入性

注册 (预期的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

印度
- Haryana
  - Rohtak、Haryana、印度、124001
    - 招聘中
    - Post Graduate Institute of Dental Sciences

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年至 25年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Patients with age between 16-25 years
Patients with Angle's class II division 1 malocclusion requiring bilateral extraction of maxillary first premolars.
Overjet of ≤ 10mm
No debilitating systemic disease.
No radiographic evidence of bone loss.
No history of periodontal disease/ therapy.
No smoking habit.
Probing depth of not more than 3mm in all teeth.

Exclusion Criteria:

Presence of any signs and symptoms of gingival and periodontal diseases.
Overjet more than 10mm.
Long-term drug history.
Systemic diseases.
Evidence of bone loss.
Smoking habit.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Piezocision on Experimental Side A Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome to accelerate maxillary canine retraction	程序：Piezocision Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome. These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle . The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.
实验性的：Micro-osteoperforations on Experimental side B Three MOPs with the help of mini-implant screw driver,mesial and distal to canine(in a vertical line) with the help of minisrew implant driver to accelrate maxillary canine retraction	程序：Micro-osteoperforations Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2). These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised. The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added. The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP

参与者组/臂

干预/治疗

实验性的：Piezocision on Experimental Side A

Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome to accelerate maxillary canine retraction

程序：Piezocision

Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome. These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle . The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.

实验性的：Micro-osteoperforations on Experimental side B

Three MOPs with the help of mini-implant screw driver,mesial and distal to canine(in a vertical line) with the help of minisrew implant driver to accelrate maxillary canine retraction

程序：Micro-osteoperforations

Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2). These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised. The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added. The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Measurement of rate of canine retraction 大体时间：4th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	4th week
Measurement of rate of canine retraction 大体时间：8th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	8th week
Measurement of rate of canine retraction 大体时间：12th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	12th week
Measurement of rate of canine retraction 大体时间：16th week	Distal movement of maxillary canine is measured in mm with the help of electric digital caliper or acrylic plug method after beginning of maxillary canine retraction	16th week

次要结果测量

结果测量	措施说明	大体时间
Assessment of pain/discomfort level 大体时间：at the beginning of canine retraction	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	at the beginning of canine retraction
Assessment of pain/discomfort level 大体时间：24 hours	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	24 hours
Assessment of pain/discomfort level 大体时间：7th day	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	7th day
Assessment of pain/discomfort level 大体时间：28th day	The participants will be asked to assess their level of discomfort on the day of initiation of canine retraction with visual analog scale(VAS).	28th day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Postgraduate Institute of Dental Sciences Rohtak

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月25日

初级完成 (预期的)

2021年9月1日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2020年12月14日

首先提交符合 QC 标准的

2021年2月4日

首次发布 (实际的)

2021年2月8日

研究记录更新

最后更新发布 (实际的)

2021年2月8日

上次提交的符合 QC 标准的更新

2021年2月4日

最后验证

2021年2月1日

"Effects of Piezocision vs Micro-osteoperforations on the Rate of Maxillary Canine Retraction