跳至主要内容
临床试验/NCT06798870
NCT06798870进行中(未招募)不适用

Investigation of White Spot Lesions Development During Management of Mixed Dentition Patients with Anterior Functional Shift

Mansoura University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7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
36
试验地点
1
主要终点
development of white spot lesion

研究概览

简要总结

36 patient will be divided into two equal groups. one for removable inclined plane while the other will be treated using clear aligner appliances. evaluation of the white spot lesion will be accumplished for all patients clinically before anr after completion of treatment.

详细描述

The sample size was calculated using G*Power (Version 3.1.9.4; Germany) and designed to have a power of 82% assuming type I statistical error of 5% and one-tailed statistical test based on Azeem and Hamid.13 The calculated sample was 15 patients in each group. The sample will be increased to include 36 patients: 18 patients per group for a 20% expected loss.

Patients with the age range of 9 to 12 years will be selected for the study. All patients and their parents will be informed of the procedures and will sign the informed consent. Patients who had periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene will be excluded from the study.

All patients will be randomly allocated into two groups according to the management protocol: inclined plane and clear aligner. The patients will be examined for any white spot lesion on the labial surface of the teeth in the upper and lower jaws clinically and using lateral and frontal intraoral photographs immediately before treatment and monthly along the treatment procedures. Each tooth will be evaluated, and the total lesions count will be recorded for each patient. All patients will be instructed to maintain good oral hygiene using fluoridated toothpaste daily.

Statistical analysis

The incidence of the WSL in each tooth and the total lesions count will be calculated for each patient. These data will be collected and subjected to the appropriate statistical tests using the SPSS version 20.0 software for Windows (IBM, USA).

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

blinding the data

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with the age range of 9 to 12 years with anterior crossbite will be selected for the study

排除标准

  • •periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene

研究组 & 干预措施

Removable inclined plane group

Active Comparator

removable appliance for correcting anterior crossbite

干预措施: removable appliances (Device)

clear aligner

Active Comparator

clear aligner appliance for correcting anterior crossbite

干预措施: removable appliances (Device)

结局指标

主要结局

development of white spot lesion

时间窗: 4 months

examination of the teeth clinically for detecting white spot lesion

次要结局

  • the highly incidence of white spot lesion in upper and lower teeth(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验