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临床试验/NCT06009796
NCT06009796已完成不适用

The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Rhinomanometry Measurement Parameters (Pa/cm3/sn )

研究概览

简要总结

This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance, and airway changes by applying rapid palatal expansion appliances in patients with maxillary constriction and the post-pubertal growth spurt stage.

详细描述

Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9 years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14, 15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

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
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •With a unilateral or bilateral morphological lateral crossbite
  • •Whose first molars and premolars had completely erupted at pretreatment
  • •With maxillary constriction of more than 4 mm and less than 10 mm
  • •Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs
  • •Individuals with a body mass index of 18-24
  • •Individuals with an ANB angle between 0º and 4º

排除标准

  • •craniofacial anomalies
  • •compliance problems
  • •systemic or genetic disease
  • •previous orthodontic treatment history

研究组 & 干预措施

Full Coverage Rapid Palatal Expansion (FCRPE) group:

Active Comparator

Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of all maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.

干预措施: Tooth Tissue Borne Rapid Palatal Expansion (Device)

Modified McNamara Rapid Palatal Expansion (MMRPE) Group:

Active Comparator

Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of the posterior maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.

干预措施: Tooth Tissue Borne Rapid Palatal Expansion (Device)

Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group

Active Comparator

The MARPE appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone.

干预措施: Tooth Bone Borne Rapid Palatal Expansion (Device)

Control Group

No Intervention

A control group in the same age, without maxillary constriction was also added to our study.Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance were used. Polygraphy and rhinomanometry measurements were obtained at the beginning of the follow-up and at the end of the 4-month follow-up period.

结局指标

主要结局

Rhinomanometry Measurement Parameters (Pa/cm3/sn )

时间窗: up to 1 year

-Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.

Polygraphy Measurement Parameters (event/hour)

时间窗: up to 1 year

- Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.

次要结局

  • Postero-anterior Measurement Parameters(mm)(up to 1 year)
  • Model Measurement Parameters(mm)(up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Yağcı

PROFESSOR

TC Erciyes University

研究点 (1)

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