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临床试验/NCT07522216
NCT07522216进行中(未招募)不适用

Effect of Clear Aligner Wear Protocol on External Root Resorption: A Randomized Controlled Clinical Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
52
试验地点
1
主要终点
Root resorption

研究概览

简要总结

The aim of this two-arm randomized clinical trial was to compare the effect of 7-day and 14-day orthodontic clear aligner wear protocols on external apical root resorption (EARR) and pain perception

详细描述

Fifty adult patients (21 Male and 29 female with a mean age of 23.7 ± 1.8) presented at the postgraduate orthodontic clinics at Jordan University of Science and Technology (JUST) were randomly allocated into a 7-day or 14-day aligner change protocol. Each patient underwent a standardized series of digital periapical radiographs (three upper and three lower). Baseline radiographs (T0) were taken before the initiation of treatment, and follow-up radiographs (T1) were collected after six months of aligner therapy.

EARR was measured from a line drawn at the cemento-enamel junction (CEJ) to the tooth's apex before treatment (T₀), and after treatment (T1), the difference in length was calculated and graded using the Malmgren Index. Pain perception was assessed using a verbal rating scale (VRS) at six-time intervals (24 hours, first week, second week, first month, third month and sixth month). Statistical analyses were used to compare pre- and post-treatment changes within and between the groups. Multiple linear regression was used to identify predictors of EARR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with complete permanent dentition except wisdom teeth
  • Participants presented with mild to moderate malocclusion (Average degree of crowding).
  • Participants with good oral hygiene and absence of periodontal disease.
  • No history of trauma or prior orthodontic treatment.

排除标准

  • Participants with thin or petite roots.
  • Participants with pre-existing root resorption
  • Participants with endodontically treated incisors or canines.
  • Participants with history of trauma to incisors teeth
  • Participants with previous orthodontic treatment.
  • Participants with periapical pathology, ankylosisor cystic lesions.
  • Participants with medical conditions that may affecting pain or inflammatory responses.

研究组 & 干预措施

7-day aligner wearing protocol

Active Comparator

干预措施: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols (Other)

14-day aligner wearing protocol

Active Comparator

干预措施: Differnt orthodontic clear aligner wearing protocols (7-day versus 14-day wearing protocols (Other)

结局指标

主要结局

Root resorption

时间窗: 6 months

Peri-apical radiographs will be taken before and after the treatment, tooth root length will be measured before and after treatment from the radiographs

次要结局

  • Pain perception(After 24 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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