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临床试验/NCT06497244
NCT06497244招募中不适用

Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization: a Split-mouth Randomized Controlled Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
1
主要终点
rate of molar distalization

研究概览

简要总结

The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.

详细描述

The design of this randomized controlled clinical trial is a parallel group, two arms trial

  • Preparatory phase

  • Self-drilling mini-screws will be placed buccally between upper 2nd premolar and 1st molar bilaterally in the last NiTi wire insertion visit.

  • After the completion of levelling and alignment phase an intra oral scan will be made for the upper arch and a rigid stainless-steel retraction arch wire 0.017" x 0.025" will be inserted.

  • The patient will then be referred to the radiology center and a pre-retraction cone beam computed tomography (CBCT) image will be taken for the maxillary arch (T0).

  • Experimental phase

  • Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.

  • Molar distalization will started immediately after performing the MOPs using sliding jig distalizer.

  • The force will be applied to the mini-screw with the sliding jig mechanics on average 300 gm using Nickel-titanium closing coil springs.

  • Before leaving the clinic, the patient will be asked to:

  • Use chlorhexidine three times per day for 3 days after MOP applications.

  • avoid using pain killers (except Panadol when needed).

  • fill in a Numeric pain rating scale.

  • Follow up phase

  • Follow up visits will be scheduled every 4 weeks for reactivation coil spring and check TADs stability.

  • An intra oral scan for the upper arch will made every visit.

  • The study time will be continued for 6 months (T1, T2, T3, T4, T5, T6).

  • The same technique of MOP will be repeated after 2 and 4 months of follow up (T2,T4).

  • After 6 months of follow up, the final dental model will made, and the patient will be referred to the same radiology center to acquire the post-distalization CBCT.

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
Single (Outcomes Assessor)

盲法说明

The first assessor will perform the digital models & CBCT measurements blindly for each patient. The second assessor will perform the same measurements blindly to calculate the inter-observer error

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Skeletal Class I or mild Class II relationship
  • Dental class II bilaterally (non-extraction cases)
  • Full permanent dentition including 2nd maxillary molars
  • Good oral hygiene
  • Medically free

排除标准

  • Systemic diseases that may interfere with the treatment
  • Use of any medications that might have affected the biology of tooth movement
  • unilateral Class II molar relationship
  • extreme skeletal Class II relationship (ANB >7°)
  • periodontal disease or alveolar bone loss
  • Patients with dental anomalies in maxillary 1st molar

结局指标

主要结局

rate of molar distalization

时间窗: 6 months

Incremental rate of molar distalization every month by intra oral scan superimposition

total molar distalization distance by mm between T6 and T0

时间窗: 6 months

Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm

次要结局

  • The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0(6 months)
  • The effect of MOPs on 1st molar root resorption level by mm between T6 and T0(6 months)
  • The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0(6 months)
  • The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0(6 months)
  • Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale(1 week)

研究者

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

mohamed essam

Principal Investigator

Cairo University

研究点 (1)

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