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临床试验/CTRI/2025/03/083755
CTRI/2025/03/083755尚未招募不适用

Cephalometric and psychometric evaluation of changes in patients with developing Class III malocclusion treated with Rapid maxillary expansion and Reverse pull headgear-An observational study.

MES Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年10月4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
15
试验地点
1
主要终点
To evaluate and compare the cephalometric changes and psychological status using cephalometric analyses and PIDAQ questionnaire in patients with developing Class III malocclusion treated with RME and FM

研究概览

简要总结

Cephalometric and psychometric evaluation of changes in patients with developing Class III malocclusion treated with rapid maxillary expansion and reverse pull headgear-An Observational study

2.INTRODUCTION, RATIONALE, RELEVANCE

Class III malocclusion patients have distinct dentofacial growth discrepancies that manifest early in life. These include retrognathic maxilla, prognathic mandible and dentoalveolar compensations, such as increased proclination of maxillary incisors and retroclination of mandibular incisors.The treatment of Class III malocclusion varies depending on the age and severity of malocclusion and include growth modification, dental camouflage and orthognathic surgery. Intraoral and extraoral orthopaedic and functional appliances are among the therapeutic options that have been developed to address Class III dentoskeletal disharmony in its early stages. In situations of maxillary retrusion in skeletal class III cases, the rapid maxillary expansion appliance combined with face mask (RME/FM) is recognised as the cornerstone of early orthopaedic interception.Patients in the early mixed dentition respond better to RME-FM treatment than those in later stages of dental development.

Anatomical variations cause malocclusion; orthodontic treatment attempts to correct these deviations from a prescribed norm. Normative measures are typically used to evaluate malocclusion and its orthodontic repair, neglecting any potential psychological advantages. With the development of psychometric instruments to quantify this intangible aspect of health, this idea has undergone a paradigm shift. This research makes use of PIDAQ questionnaire to assess quality of life in patients treated with RME/FM.PIDAQ was first created in German and has demonstrated strong cross-cultural psychometric qualities. It was recently verified and translated into Malayalam, and it will be used in this study.

To the best of my knowledge, very few research have looked at the cephalometric and psychological effects of patients treated with RME/FM. This study therefore aims to evaluate the cephalometric changes and psychological status in terms of their subjective sense of well-being, as measured by the four-factor scale of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) in patients with developing Class III malocclusion treated with RME/FM who report to the Department of Orthodontics, MES Dental College, Perinthalmanna

RESEARCH QUESTION

How does treatment with RME/FM affect the normative outcome assessed using cephalometric analysis and patient-reported outcome assessed using PIDAQ in patients with developing Class III malocclusion at two clinical time points in the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, Perinthalmanna from 25/5/2024 to 31/12/2025?

AIM

The aim of the study is to evaluate how treatment with RME/FM affect the normative outcome assessed using cephalometric analysis and patient-reported outcome assessed using PIDAQ in patients with developing Class III malocclusion at two clinical time points in the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, Perinthalmanna.

INCLUSION CRITERIA

The inclusion criteria include

1.     Patients with developing skeletal Class III and Angle’s Class III malocclusion with maxillary deficiency and anterior and posterior crossbite indicated for RME/FM treatment in MES Dental College, Perinthalmanna.

2.     Patients in the age group between 10 to 14 years.

3.     Patients should be having healthy gingival and periodontal status.

4.     Wit’s appraisal of -2mm or less and ANB < 0 degree.

5.     Absence of CO-CR discrepancy.

EXCLUSION CRITERIA

The exclusion criteria are

1.     1.Patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate

2.     2.Presence of systemic diseases

3.     3.Daily use of anti-depressive medication

4.     4.Presence of  periodontal disease

5.     5.Patients with disorders affecting bone healing, metabolism and turn over

6.     6.Those whose legal representatives do not authorize participation in the study.

7.    7. History of facial trauma.

8.Previous orthodontic treatment

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1 Patients with developing skeletal Class III and Angles Class III malocclusion with maxillary deficiency and anterior and posterior crossbite indicated for RMEand FM treatment in MES Dental CollegePerinthalmanna 2 Patients in the age group between 10 to 14 years 3 Patients should be having healthy gingival and periodontal status 4 Wits appraisal of -2mm or less and ANB less than 0 degree 5 Absence of CO CR discrepancy.

排除标准

  • 1 Patients with congenital abnormalities such as craniofacial syndrome or cleft lip and palate 2 Presence of systemic diseases 3 Daily use of anti depressive medication 4 Presence of periodontal disease 5 Patients with disorders affecting bone healing metabolism and turn over 6 Those whose legal representatives do not authorize participation in the study 7 History of facial trauma 8 Previous orthodontic treatment.

结局指标

主要结局

To evaluate and compare the cephalometric changes and psychological status using cephalometric analyses and PIDAQ questionnaire in patients with developing Class III malocclusion treated with RME and FM

时间窗: Before treatment begins typically within a few days or weeks before the intervention starts | Post treatment After completion of active treatment once the RME and Reverse Pull Headgear treatment have concluded

次要结局

  • To assess the effect of gender on pre and posttreatment psychometric changes evaluated using PIDAQ(Before treatment begins typically within a few days or weeks before the intervention starts)

研究者

发起方
MES Dental College and Hospital
申办方类型
Other [Private Dental College and Hospital]

研究点 (1)

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