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临床试验/CTRI/2025/05/086693
CTRI/2025/05/086693尚未招募不适用

A comparative cephalometric evaluation of changes in the upper airway among patients with developing Class III malocclusion treated using two interceptive orthodontic appliances.

MES Dental college and Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate any changes in the upper airway while using the modified SEC III appliance and RME reverse pull headgear in patients with developing skeletal class III malocclusion

研究概览

简要总结

TITLE

Comparative cephalometric evaluation of changes in the upper airway among patients with developing class III malocclusion treated using twointerceptive orthodontic appliances.

INTRODUCTION, RATIONALE, RELEVANCE

Breathing is one of the primary essential processes of the human body, and it is facilitated by the upper airway. Orthodontists have always been interested in investigating the upper airway, with the primary goal being to explain the relationship between pharyngal features and the growth and development of the craniofacial complex. Predisposing factors that block the upper airway include obstructive processes of morphologic, physiologic, or pathologic nature, such as tumors, polyps, allergic and chronic rhinitis, infections, irritant environmental factors, congenital nasal deformities, tonsil, and hypertrophy etc. When that occurs, a functional imbalance leads to an oral breathing pattern that might modify the shapes of the dental arch and the face morphology, ultimately resulting in a malocclusion.

One of the most difficult malocclusions to treat is skeletal Class III malocclusion. Studies on the etiology of Class III malocclusion have shown that 32–63% of patients with a skeletal Class III malocclusion have a retruded maxilla or a combination of a retruded maxilla and excessive mandibular growth. A mixture of various treatment methods, such as chin cups, SEC III appliance, skeletal anchorage systems, removable functional appliances, fixed appliances, and removable appliances are possible approaches. The size of the maxilla and the mandible has been shown to correlate with the pharyngeal airway dimensions. A skeletal change that can occur from the orthopedic treatment of Class III malocclusion is the alteration of the size of the airway. The primary effects of correction with the SEC III appliance were mainly skeletal and slightly dentoalveolar in nature with the greatest impact on maxillary and mandibular position, with significant amount of sagittal advancement in maxilla. The RME- reverse pull headgear induces a significant increase of the inter maxillary vertical relationships.

Airway dimensions can be assessed using different imaging techniques, one of which is lateral cephalometric radiography. Lateral cephalograms are obtained routinely as a part of orthodontic diagnostic procedures.   The accuracy of airway measurements from lateral cephalograms, cone-beam computed tomographic (CBCT) lateral reconstructions, and CBCT axial planes, airway linear measurements are reliable, with both lateral cephalograms and CBCT reconstruction. Cephalometric analysis allows the measurement of the airway dimensions without exposing the patient to additional radiation.In this study pre-and post-treatment lateral cephalometric radiographs of 30 patients who will be treated using two interceptive orthodontic appliances in developing class III malocclusion will be used. Group I patients will be treated using a reverse pull headgear after rapid maxillary expansion (RME).Group II patients will be treated using the modified SEC III appliance having two occlusal splints with Class III elastics, RME, and a chin cup as part of it.

NOVELTY

Currently studies evaluating the impact of airway dimensions in patients receiving RME -reverse pull headgear/ The modified SEC III appliance treatment for developing skeletal class III malocclusion are not available in the literature and there is a lacuna in the literature. So, the purpose of this study is to assess whether there are any appreciable variations in the airway dimensions when employing two interceptive orthodontic appliances—the modified SEC III appliance and RME -reverse pull headgear in patients with developing skeletal class III malocclusion reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College Perinthalmanna.

RESEARCH QUESTION

Will there be a noticeable difference in airway dimensions between thetwo interceptive orthodontic appliances(the modified SEC III appliance and RME -reverse pull headgear) in patients with developing skeletal class III malocclusion who are reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, from May 31, 2024 to December 31, 2025?

AIM

To evaluate any changes in the upper airway while using the modified SEC III appliance and RME -reverse pull headgear in patients with developing skeletal class III malocclusion who are reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College Perinthalmanna.

INCLUSION CRITERIA

Patients with developing skeletal Class III Malocclusion will be included in the study

Angles class III molar and canine relationship with anterior and posterior crossbite

Absence of CO CR discrepancy

Wits appraisal of 2 mm

Skeletal maturation CVMI 2&3 stage

EXCLUSION CRITERIA

Patients with facial asymmetry

Patients with CVMI stage 4 onward

Patients with a history of previous facial trauma tonsillectomy maxillofacial surgery  adenoidectomy

Patients with congenital syndromes

History of metabolic disorders

Presence of periodontitis

History of previous orthodontic orthopaedic treatment

Presence of decayed molar teeth

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Patients with developing skeletal Class III Malocclusion will be included in the study Angles class III molar and canine relationship with anterior and posterior crossbite Absence of CO CR discrepancy Wits appraisal of 2 mm Skeletal maturation CVMI 2&3 stage.

排除标准

  • Patients with facial asymmetry Patients with CVMI stage 4 onward Patients with a history of previous facial trauma tonsillectomy maxillofacial surgery adenoidectomy Patients with congenital syndromes History of metabolic disorders Presence of periodontitis History of previous orthodontic orthopaedic treatment Presence of decayed molar teeth.

结局指标

主要结局

To evaluate any changes in the upper airway while using the modified SEC III appliance and RME reverse pull headgear in patients with developing skeletal class III malocclusion

时间窗: Pretreatment taken within 1 week before appliance placement Posttreatment records taken after 10 weeks upon completion of active phase

次要结局

  • To evaluate changes in the upper airway in male & female patients with developing skeletal Class III malocclusion while using the modified SEC III appliance & rapid maxillary expansion with reverse pull headgear(Pretreatment taken within 1 week before appliance placement Posttreatment records taken after 10 weeks upon completion of active phase)

研究者

发起方
MES Dental college and Hospital
申办方类型
Other [Private Dental College]
责任方
Principal Investigator
主要研究者

RENJINI KS

MES Dental college and Hospital

研究点 (1)

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