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临床试验/NCT06478771
NCT06478771已完成不适用

Does the Patient Choice of Retainer Affect Retention Success?: A Randomized Controlled Study

Hacettepe University2 个研究点 分布在 2 个国家目标入组 128 人开始时间: 2021年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Stability

研究概览

简要总结

Aim of the Study: To determine whether allowing the patient to choose the type of retainer affects the success of retention in terms of stability and patient satisfaction.

Hypothesis: Allowing the patient to choose their retainer can increase the success of retention.

Design: Two-arm parallel group randomized controlled clinical trial

详细描述

This study investigates whether allowing patients to choose the type of retainer-fixed or removable-affects the success of orthodontic retention in terms of stability and patient satisfaction. The hypothesis is that patient autonomy in selecting their retainer type can enhance retention success. Conducted as a two-arm parallel group randomized controlled trial, the study involves patients who have completed fixed appliance treatment. Participants are randomly assigned to either the intervention group, where they choose their retainer type after being informed of the pros and cons, or the control group, where the clinician decides the retainer type.

The primary outcome of the study is the stability of the orthodontic treatment, with secondary outcomes including retainer survival, oral health, and patient satisfaction. Stability is measured using indices such as Little's irregularity index, inter-canine width, and overjet, among others. Oral health is evaluated based on caries presence, sulcus depth, and gingival bleeding. Retainer survival is monitored by incidents of losing or breaking the retainer. Patient satisfaction is assessed through a detailed questionnaire covering aspects such as retainer usage, comfort, and perceived value. Due to the nature of the intervention, blinding is not possible for operators, participants, or assessors. This study aims to provide insights into how patient choice influences the outcomes of orthodontic retention, potentially guiding future clinical practices towards enhanced patient satisfaction and treatment success.

This study aims to provide valuable insights into the impact of patient autonomy on orthodontic retention outcomes. By comparing patient-chosen and clinician-chosen retainer types, the research seeks to enhance our understanding of factors contributing to successful orthodontic retention and overall patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

盲法说明

In this study, masking (blinding) is not possible due to the nature of the intervention. Both the participants and care providers, as well as the outcome assessors, will be aware of the type of retainer being used.

入排标准

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

入选标准

  • Patients older than age 12
  • Patients who have been treated with fixed orthodontic appliances
  • Patients with good standard of oral hygiene

排除标准

  • Patients with initial diastema or other significant spacing
  • Patients with dentofacial syndromes/cleft lip and palate
  • Patients who had orthodontic treatment before
  • Patients with hypodontia (more than one tooth missing, except third molars)
  • Patients who have undergone orthognathic surgery

结局指标

主要结局

Stability

时间窗: 2 years

Stability will be assessed using Little's Irregularity Index at baseline and 24 months post-treatment. The index measures the alignment of anterior teeth, with scores ranging from 0 (perfect alignment) to 10 (severe misalignment). Lower scores indicate better outcomes.

次要结局

  • Patient satisfaction(2 years)
  • Retainer survival(2 years)
  • Oral health(2 years)

研究者

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

Irmak Ocak

Assistant professor

Hacettepe University

研究点 (2)

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