Investigation of the Functional, Aesthetic, and Quality-of-life Effects of Combined Surgical-orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Skeletal maxillary expansion measured with 3D scans
研究概览
简要总结
This study aims to compare two different methods for maxillary expansion in adult patients with transverse maxillary deficiency. Participants will receive either miniscrew-assisted rapid palatal expansion (MARPE-MICRO-4). We want to compare the surgically assisted rapid palatal expansion (SARPE) and the non surgical/conservative method. Clinical (3D scans of the upper jaws) measurements will be used to evaluate skeletal expansion and stability over time. Approximately 90 adult patients will be included and followed for 12 months. The results of this study may help clinicians choose the most appropriate treatment method for adult maxillary expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 transverse maxillary deficiency requiring maxillary expansion
- •Indication for either non-surgical (MARPE) or surgically assisted (SARPE) maxillary expansion
- •Permanent dentition
- •Ability to understand the study procedures and provide informed consent
排除标准
- •Previous maxillary expansion treatment
- •Craniofacial syndromes or cleft lip/palate
- •Severe periodontal disease
- •Active oral infection
- •Systemic conditions affecting bone metabolism
- •Pregnancy or breastfeeding
- •Inability to comply with study procedures or follow-up visits
研究组 & 干预措施
Surgically Assisted Rapid Maxillary Expansion
Participants in this arm will undergo surgically assisted rapid palatal expansion (SARPE). The procedure will include surgical weakening of the maxillary sutures followed by maxillary expansion using a palatal expansion appliance. The appliance will be activated according to a standardized protocol. Clinical and radiographic assessments will be performed to evaluate treatment outcomes.
干预措施: SARME (Procedure)
Non-Surgically Assisted Rapid Maxillary Expansion
Participants in this arm will undergo non-surgical maxillary expansion using a miniscrew-assisted rapid palatal expansion (MARPE) appliance. The appliance will be anchored to the palate using temporary anchorage devices (TADs) and activated according to a standardized expansion protocol. No surgical assistance will be performed in this group. Clinical and radiographic assessments will be used to evaluate treatment outcomes.
干预措施: MARPE (Device)
结局指标
主要结局
Skeletal maxillary expansion measured with 3D scans
时间窗: Baseline to 6 months after completion of maxillary expansion.
Changes in intermolar and intercanine width will be measured on digital dental models.
次要结局
- Buccal tipping of posterior teeth measured on 3D digital models(Baseline to 6 months after completion of maxillary expansion)