A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Stability of correction of transverse deficiency
研究概览
简要总结
This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.
详细描述
All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.
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 of either patient or clinician is not possible. However, blinding was ensured during analyzing the data. All digital models and x-rays were coded and shuffled before they were evaluated and measured.
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age ranges from 20-25 years.
- •Post pubertal adolescent
- •Skeletal transverse deficiency with unilateral or bilateral cross-bite
- •Extraction is not indicated in the lower arch.
- •Upper permanent dentition is erupted up to the second molars.
- •Average facial vertical growth pattern.
- •Space deficiency in the upper arch is less than 8 mm
排除标准
- •Diseases and medications those are likely to affect bone biology.
- •Evidence of root resorption.
- •Poor oral hygiene.
- •Previous orthodontic treatment.
- •Evidence of bone loss.
- •Active periodontal disease.
- •Craniofacial congenital anomalies, such as cleft lip and palate.
- •Pregnant females.
- •Presence of oral habits.
结局指标
主要结局
Stability of correction of transverse deficiency
时间窗: about 6 months
by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research
Pain experience during activation of expander by visual analogue scale ( VAS)
时间窗: about 1 months
VAS: 0 ( no pain), 10 (unbearable pain)
Number of days till diastema appearance
时间窗: about 1 month
(days)
Amount of skeletal expansion
时间窗: about 1 month
(mm)
Skeletal, Dental & Nasal readings
时间窗: measured before treatment and after 6 month of treatment
from CBCT and scanned models measured in degrees \& mm
次要结局
未报告次要终点
研究者
Motaz Elshehaby
principal investigator
Mansoura University