Activation Intervals Effects on Non-surgical Semi-rapid Maxillary Expansion in Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Buccal bone area evaluation
研究概览
简要总结
OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.
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)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth
- •The needs of maxillary expansion for the correction of their malocclusion
- •Age range from 20 to 35
- •Non-gingivitis or untreated caries at the start of orthodontic treatment
- •Probing depth less than 4mm across the entire dentition
- •Gingival index ≤ 1
- •Plaque index ≤ 1
排除标准
- •Increased Monson curve
- •Patients with systemic disease
- •Patients with congenital anomalies
- •Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- •Pregnancy
- •Poor oral hygiene for more than two visits
- •Radiographic evidence of moderate to severe bone loss
- •Current periodontal disease
- •Patients who smoke
- •Individuals with inadequately treated endodontic problems in the study area.
研究组 & 干预措施
Every four days RPE activation
Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every four days until getting the require expansion needed
干预措施: semirapid maxillary expansion (SRME) (Procedure)
Every week RPE activation
Non-surgical semi-rapid maxillary expansion (SRME) with the time intervals activation every week until getting the require expansion needed
干预措施: semirapid maxillary expansion (SRME) (Procedure)
结局指标
主要结局
Buccal bone area evaluation
时间窗: Change from baseline to 6 months
Measure in CBCT in a coronal slice, thickness of the buccal bone in upper first premolars and upper first molars
Transversal distance between upper canines, first premolars and upper first molars
时间窗: Change from baseline to 6 months
Distance between mesial fosa of each upper canines, first premolars and distance between central fosa of each upper first molars
Posterior teeth buccal inclination
时间窗: Change from baseline to 6 months
Measure in CBCT in a coronal slice between the palatal plane and the dental axis
次要结局
- Clinical attachment level (CAL)(Change from baseline to 6 months)
- Bleeding on probing (BP)(Change from baseline to 6 months)
- Evaluation of the perception of pain by the patient (VAS)(Change from baseline to 6 months)
- Probing depth (PD)(Change from baseline to 6 months)
- Soft tissue recession (STR)(Change from baseline to 6 months)
研究者
Sonia Patricia Plaza
Director, Research Orthodontic Department, Principal Investigator.
Fundación Universitaria CIEO