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
- 1
- 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.
- •7. Pregnant females.
- •Presence of oral habits.
研究组 & 干预措施
MARPE with MOP
干预措施: MARPE with MOP (Procedure)
MARPE without MOP
干预措施: MARPE without MOP (Procedure)
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
Number of days till diastema appearance
时间窗: about 1 month
(days)
Pain experience during activation of expander by visual analogue scale ( VAS)
时间窗: about 1 months
VAS: 0 ( no pain), 10 (unbearable pain)
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