跳至主要内容
临床试验/CTRI/2021/07/035044
CTRI/2021/07/035044招募中不适用

Treatment of Class III malocclusion using Modified Fixed Reverse Twin-Block Therapy - A prospective Cephalometric and Magnetic Resonance Imaging Study

ESIC Dental College Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年7月23日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
evaluate the effectiveness of modified fixed RTB as a functional treatment modality for Class III correction during adolescence.

研究概览

简要总结

Inspite of lower prevalence rate of Class III malocclusion compared to Class I and Class II in global and Indian population, Class III jaw relationships often present a unique therapeutic challenge  due to complex interplay between environmental and innate factors involved  in the genesis of these malocclusions. By utilization of Cephalometric Radiography and Magnetic Resonance Imaging (MRI), this clinical study proposes to assess dentoalveolar, skeletal and soft-tissue effects including adaptive TMJ mechanisms (alterations within the condyle-glenoid fossa complex and the positional changes of the glenoid fossa in the cranium) in Class III adolescents treated with modified fixed RTB therapy accompanied by fixed appliances. This would help formulate more satisfying treatment plans while taking into consideration the concerns and expectations of the patients.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
14.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • (i) Age from 14 years upto18 years, (ii) Established Angle Class III malocclusion with an anterior crossbite involving three to four incisors in Intercuspal position (ICP), (iii) Ability to achieve edge-edge incisor relationship in Retruded contact position (RCP) with no pain or discomfort in TMJ (iv) Minimal dental decompensation of the maxillary and mandibular incisors.
  • (v)-4ÌŠ< ANB < 0ÌŠ (vi) Normodivergent to mild hyperdivergent growth pattern (vii) Concave facial profile (viii) Minimal or no crowding in the maxillary and mandibular arches (ix) Full complement of permanent teeth (third molars excluded) (x) Transition to Maturation phase of growth based on Cervical Vertebrae Maturity Indicators (CVMI) assessment.

排除标准

  • (i) Class III malocclusion not amenable to functional correction (ii) Presence of true laterognathism or any syndromic craniofacial deformity such as cleft lip and/or palate or any systemic disease that could affect normal growth of the body and/or the jaws.
  • (iii) Claustrophobia and unwillingness to participate in the study (iv) Patients exhibiting allergy/delayed hypersensitivity to methylmethacrylate resins (v) Patients with associated severe TMJ symptoms and any other systemic problems.

结局指标

主要结局

evaluate the effectiveness of modified fixed RTB as a functional treatment modality for Class III correction during adolescence.

时间窗: 6-9 months

次要结局

  • 1) To assess dentoalveolar, skeletal and soft tissue effects of modified fixed RTB therapy for Class III correction during adolescence.(2) To compare temporomandibular joint adaptation changes especially disk-condyle-fossa relationship following treatment of Class III malocclusion using modified fixed RTB and fixed appliances.)

研究者

申办方类型
Government medical college

研究点 (1)

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