Efficacy of Mini-Implant-Assisted Maxillary Expansion on Late Adolescents and Adults and Its Effects on Nasal Permeability and Airway Volume Using Three Different Activation Protocols: A Randomized Controlled Trial (MARPE_1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- MPSM: mid-palatal suture middle molars
研究概览
简要总结
Transverse maxillary deficiency is a common orthodontic issue, affecting around 10% of adults. Late adolescents and adults often require more force to expand the midpalatal suture due to its increased interdigitation. This study aims to assess the effectiveness of MARPE in this demographic and determine the best activation protocol for non-surgical maxillary expansion using mini-screw-supported appliances. Additionally, the study will evaluate the effectiveness of MARPE on nasal permeability and airway volume.
详细描述
The study design comprised a three-arm, parallel-group randomized controlled trial (RCT) conducted at the Orthodontics clinic of Brussels University Hospital. Patients were randomly allocated into one of three groups:
- Continuous rapid activation protocol: Patients received one activation of 0.17 mm per day until reaching the clinical goal.
- Continuous slow activation protocol: Patients underwent two activations (0.33 mm) per day for the first 7 days, followed by one turn forward every third day (0.17 mm / 3 days).
- Force-controlled polycyclic protocol: Patients underwent two activations (0.33 mm) per day for the first 7 days. Then, the hex nut was turned 6 sides backward, followed by 6 sides forward after 15 minutes. Additionally, the device was activated by 0.17 mm every third day.
Intervention:
All patients underwent maxillary expansion with MARPE. Four orthodontic mini-screws were inserted under local anesthesia using a surgical guide and motor. Surgical incision was not required, and predrilling was performed if necessary. The MARPE remained in place for 12 months after expansion to allow bone remodeling in the midpalatal suture. Fixed straight-wire treatment commenced 2 months after expansion termination. Patients underwent retention check-ups at 6 and 12 months post-expansion, and expansion screws and mini-screws were removed after 12 months or before orthognathic surgery, if applicable.
The specific aims of the study were to evaluate the success rate of nonsurgical maxillary expansion, compare the efficacy of the three activation protocols, assess and compare complications, analyze the correlation between success rate and Midpalatal Suture Maturation Stage (MPS), age, and sex, and measure nasal permeability variation using anterior rhinomanometry.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •from the age of 16 onwards
- •who presented with transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite).
排除标准
- •history or presence of maxillofacial surgery, cleft lip and palate, craniofacial anomalies or syndromes, congenital tooth anomalies, and periodontal disease.
- •Patients who had previously palatal expansion were excluded also.
- •Presence of anatomic or pathological obstacle of the palatal mini-screw insertion (impacted tooth, tumor.)
- •refusal of study participation
结局指标
主要结局
MPSM: mid-palatal suture middle molars
时间窗: up to 6 months
the width of the mid-palatal suture measure in millimeters at the level of the first molars
UID
时间窗: up to 6 months
distance in millimeters from the most external point of the right frontozygomatic suture to the most external point of the left frontozygomatic suture.
IMW: intermolar width
时间窗: up to 6 months
Transverse distance in millimeters between the left and right maxillary M1 mesiocentral fossae
PAW: palatal alveolar width
时间窗: up to 6 months
Transverse distance between in millimeters the left and right most cervical medial limits of the palatal alveolar process
TI : tooth inclination
时间窗: up to 6 months
2D inner angle (in degrees) between the palatal plane and the left and right line running through the palatal apex and the mesiobuccal fossa or the mesial fossa
PNS-PNS
时间窗: up to 6 months
distance in millimeters between the right posterior nasal spine and the left posterior nasal spine after the maxillary expansion
IPW: interpremolar width
时间窗: up to 6 months
Transverse distance in millimeters between the left and right maxillary P1 mesial fossae
LID:
时间窗: up to 6 months
distance in millimeters from the most external point of the right zygomaticomaxillary suture to the most external point of the left zygomaticomaxillary suture
MSW: midpalatal suture width
时间窗: up to 6 months
Transverse distance in millimeters between the medial limits of the left and right palatal process at the palatal floor
ICW: intercanine width
时间窗: up to 6 months
Transverse distance in millimeters between the left and right maxillary canine buccal cusp tips
ANS-ANS
时间窗: up to 6 months
the distance in millimeters between the right anterior nasal spine and the left anterior nasal spine after the maxillary expansion
ZMA
时间窗: up to 6 months
width in millimeters between the right and left zygomatic arches at its widest point at the most inferior level of the orbits.
NCW: nasal cavity width
时间窗: up to 6 months
Transverse distance in millimeters between the left and right most lateral point of the nasal cavity
次要结局
- NCV: nasal cavity volume(up to 6 months)
- RT resistance total(up to 6 months)
- OMCSA: oropharynx minimum cross-sectional area(up to 6 months)
- RMSV : right maxillary sinus volume(up to 6 months)
- NPV nasopharynx volume(up to 6 months)
- OPV oropharynx volume(up to 6 months)
- AV: Accumulated volume(up to 6 months)
- LMSV : left maxillary sinus volume(up to 6 months)