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临床试验/CTRI/2025/07/091614
CTRI/2025/07/091614招募中2/3 期

Comparison of tooth movement, root resorption and predictability of canine retraction using direct printed clear aligners with versus without attachment: A Cone-beam computed tomography-based study

Dr Keerthi Raja S1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年8月4日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
14
试验地点
1
主要终点
translation of canine and predictability

研究概览

简要总结

Title

Comparison of Tooth Movement, Root Resorption, and Predictability of Canine Retraction Using Direct Printed Clear Aligners with Versus Without Attachment: A Cone-Beam Computed Tomography-Based Study

This split-mouth, in-vivo clinical study aims to compare the efficiency, predictability, and biological effects of canine retraction using in-house direct-printed clear aligners with and without attachments. The study will be conducted among orthodontic patients indicated for bilateral maxillary first premolar extractions and aligner therapy.

A total of 7 patients (14 samples) will be recruited following specific inclusion criteria such as age above 18, Class I or II malocclusion, good oral hygiene, and absence of systemic or periodontal disease. Each patient will undergo a split-mouth intervention, where one side of the arch will be randomly assigned to receive aligners with attachments, while the opposite side will receive aligners without attachments. Attachments include vertical rectangular shapes on canines to facilitate retraction and horizontal attachments on premolars and molars for anchorage. All aligners will be fabricated using a 3D printer and biocompatible resin and will be worn for 22 hours/day, with tray changes every 10 days over a 3-month period.

Cone-Beam Computed Tomography (CBCT) will be used at baseline (T0) and after retraction (T2) to obtain 3D models and assess treatment changes. Tooth movement will be measured in sagittal, transverse, and vertical planes, using defined anatomical reference planes and points. Parameters evaluated will include distalisation, tipping, rotation, extrusion, and bodily movement. In addition, root resorption will be measured by comparing root lengths between pre- and post-treatment CBCT scans.

Predictability will be assessed by comparing predicted movement (T1) with actual outcomes (T2) using Geomagic software for 3D superimposition, referencing the palatal vault and rugae. The main outcomes include differences in tooth movement, the extent of root resorption, and overall treatment predictability between the two groups.

This study addresses a critical gap in evidence regarding the role of attachments in improving the biomechanical performance of aligners during canine retraction. Findings from this research may influence clinical decision-making, aligner design, and enhance patient outcomes by supporting safer and more efficient orthodontic treatment protocols.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Age greater than 18 years Class I or II malocclusion Good general and oral health No dental caries Good oral hygiene Indication for clear aligner therapy.

排除标准

  • Crowding less than 4mm (Little’s Irregularity Index) Systemic diseases affecting bone metabolism Craniofacial anomalies or syndromes Missing or previously extracted permanent molars Periodontal disease, pregnancy, history of orthodontic treatment Smokers and non-compliant patients.

结局指标

主要结局

translation of canine and predictability

时间窗: 3months

次要结局

  • root resorption(3 months)
  • anchorage loss(3 months)
  • periodontal status(monthly)

研究者

发起方
Dr Keerthi Raja S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr.Keerthi Raja S

Tagore dental college and Hospital

研究点 (1)

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