Comprehensive Evaluation of Treatment Outcomes in Patients Treated With Palatal Temporary Skeletal Anchorage Devices
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hospital of the Ministry of Interior, Kielce, Poland
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in maxillary width before and after TSAD-supported orthodontic treatment
概览
简要总结
This study aims to evaluate clinical outcomes, patient-reported quality of life, the precision of surgical guides used for placing orthodontic mini-screws, and potential complications associated with the use of palatal temporary skeletal anchorage devices (TSADs) in orthodontically treated patients. The main questions it aims to answer are:
- What is the clinical effectiveness of palatal TSADs in orthodontic treatment outcomes?
- How do palatal TSADs affect the quality of life in orthodontic patients?
- How accurately do surgical guides transfer the digitally planned positions of mini-screws to their actual positions?
- What are the complications associated with the use of palatal TSADs in orthodontic treatment?
Participants will:
- Receive orthodontic treatment involving the placement of palatal TSADs
- Complete validated, standardized questionnaires assessing quality of life
- Be evaluated for skeletal and dental changes and monitored for clinical and technical complications throughout the course of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a malocclusion requiring palatal temporary skeletal anchorage devices (TSADs)
- •No previous treatment involving TSADs
- •Lack of systemic comorbidities
- •Signed informed consent (and parental consent for minors)
排除标准
- •Presence of uncontrolled systemic diseases or conditions that contraindicate orthodontic treatment or the placement of mini-screws
- •Poor oral hygiene
- •Allergies to materials used in mini-screws or associated orthodontic appliances
- •Lack of patient consent for study participation
结局指标
主要结局
Change in maxillary width before and after TSAD-supported orthodontic treatment
时间窗: Baseline (pre-treatment) and through completion of orthodontic treatment (up to 24 months).
This primary outcome measure assesses changes in palatal width (in millimeters) among patients undergoing orthodontic treatment with temporary skeletal anchorage devices (TSADs). Measurements of palatal width will be conducted at two distinct time points: at baseline (prior to initiation of orthodontic treatment) and upon completion of the treatment. Measurements will be conducted using imaging techniques.
次要结局
- Incidence and Types of Complications Associated with Orthodontic Treatment Using Palatal TSADs(Periprocedural period and up to 8 weeks post TSAD insertion.)
- Patient-Reported Quality of Life During TSAD-Supported Use of the Palatal Appliance(Baseline (Day 0, day of appliance placement) through 8 weeks post-insertion.)
- Accuracy of Patient-Specific Surgical Guides for Palatal Mini-Screw Placement(Periprocedural (Day 0, immediately after placement of mini-screws using the surgical guide).)