Evaluation of the Effect of Different Rapid Maxillary Expansion Appliances on Airway by Acoustic Rhinometry: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Correction of posterior crossbite
研究概览
简要总结
Rapid maxillary expansion (RME) is an orthodontic treatment based on the principle of opening the midpalatal suture with the effect of orthopedic forces. The aim of this randomized clinical study was to evaluate and compare the effects of tooth-borne, tooth-tissue borne, and bone-borne rapid maxillary expanders on nasal airway by using AR. The null hypothesis was that there is no difference for the effect on nasal airway between the appliances.
详细描述
Introduction
The aim of this 3-arm parallel trial was to compare the effects of tooth-borne (Hyrax), tooth tissue-borne (KBME) and bone-borne (MIDME) rapid maxillary expansion (RME) appliances on nasal airway with acoustic rhinometry (AR).
Methods: Fourty-six 12- to 14-years-old patients with narrow maxilla were randomly allocated into 3 study groups according to the type of RME appliance: tooth-borne, tooth tissue-borne and bone-borne. Participants were recruited from the Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Turkey. During the RME treatment, the same protocol was applied to all patients and the expansion screws were activated twice a day (0.4 mm/day). Computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. The outcome assessor was blinded; however, it was not feasible to blind either operator or patients. The primary outcome of this study was the correction of posterior crossbite. Secondary outcomes included AR assessment of nasal airway dimensions as nasal volume, the minimal cross-sectional area (MCA) 1 and 2. AR measurements were obtained before treatment (T0), after active expansion (T1), and at 3 months-follow-up (T2). One-way analysis of variance (ANOVA) and a Bonferroni test was used for inter-group comparison and two-way ANOVA was used for intra-group evalaution.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
- •Bilateral crossbite and need for RME,
- •maxillary and mandibular permanent teeth fully erupted,
- •willingness to participate in the study
排除标准
- •the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
- •having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
- •history of previous orthodontic treatment.
结局指标
主要结局
Correction of posterior crossbite
时间窗: After active expansion (up to 3 weeks) (T1).
The palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
次要结局
- Increasing nasal cavity area-1(At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2))
- Increasing nasal cavity area-2(At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2))
- Increasing nasal cavity volume(At baseline (T0), after active expansion (up to 3 weeks) (T1) and after 3 months retention period (T2))
研究者
Gökçenur Gökçe
Assistant professor
Izmir Katip Celebi University