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临床试验/CTRI/2025/03/083640
CTRI/2025/03/083640尚未招募不适用

Cephalometric and Psychometric evaluation of changes in patients with developing Class III malocclusion treated with the modified Splint Class III Elastics and Chin cup appliance modified sec III 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4月10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 psychological effects using PIDAQ and skeletal dental, soft tissue changes using cephalometric in patients with developing class III malocclusion undergoing modified SEC III protocol at two-time intervals: pre-treatment and post treatment

研究概览

简要总结

CEPHALOMETRIC AND PSYCHOMETRIC EVALUATION OF CHANGES IN PATIENTS WITH DEVELOPING CLASS III MALOCCLUSION TREATED WITH THE MODIFIED SPLINT, CLASS III ELASTICS AND CHIN CUP APPLIANCE (MODIFIED SEC III )- AN OBSERVATIONAL STUDY

INTRODUCTION

Intraoral and extraoral appliances are two of the therapeutic options that have been established to treat Class III dentoskeletal disharmony at an early stage. In skeletal class III malocclusion with maxillary retrusion, rapid maxillary expansion combined with the face mask (RME/FM) is recognized as the cornerstone of early orthopedic interception. The Splint, Elastic, Chin cup (SEC III) appliance—which combines two occlusal acrylic splints with Class III elastics and a chin cup—was first introduced in the 1980s. Both SEC III and RME/FM protocols are efficient treatment modalities for Class III dentoskeletal disharmony. The SEC III protocol produces more favorable control in intermaxillary vertical relationships than the RME/FM therapy. The modified SEC III protocol with RME, splints, Class III elastics with a chin cup will improve the treatment efficacy of developing Class III malocclusion. It allows greater intrusion of posterior teeth and helps in the anti-clockwise mandibular rotation and correction of overbite. It is useful in patients with vertical growth pattern.

Understanding the impact of malocclusion on quality of life requires an awareness of one’s oral health perception. The effects of malocclusion on a patient’s function, appearance, social relationships and mental health have been documented. Anatomical variations cause malocclusion; orthodontic  treatment attempts to correct these deviations from a prescribed norm.It has been demonstrated to have effects on the patient’s oral health-related quality of life (OHRQoL), in addition to psychological and physical effects. Normative measures are typically used to evaluate the correction of malocclusion, neglecting any potential psychological advantages.  This research makes use of Psychosocial impact of dental aesthetic questionnaire (PIDAQ) questionnaire to assess quality of life in patients treated with the modified SEC III appliance. It was recently verified and translated into Malayalam, and it was used in this study. Social, psychological, and aesthetic concerns are the three aspects of psychosocial impact that are measured by the PIDAQ.

RATIONALE AND RELEVANCE

This research compares changes in quality of life by PIDAQ from a patient’s perspective with cephalometric evaluation in the orthodontist’s perspective in patients treated with modified SEC III appliance. To the best of my knowledge, there is a gap in the literature regarding comparison of the psychological changes along with cephalometric changes in patients treated with modified SEC IIIappliance in the Kerala population.

RESEARCH QUESTION

How does treatment with modified SEC III appliance 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 30/5/2024 to 31/12/2025?

AIMThe aim of the study is to evaluate how treatment with the modified SEC III appliance 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 CRITERIA1.     Patients with developing skeletal Class III malocclusion having bilateral jaw discrepancy (combination of maxillary retrognathism and mandibular prognathism) will be included in the study.

2.     Patients in the age group 10-14years

3.     Angle’s Class III malocclusion with Anterior and posterior Crossbite

4.     Wit’s appraisal of -2.0 mm or less and ANB < 0 degrees

5.     Skeletal maturation CVMI 2&3 stage

6.     Absence of CO-CR discrepancy (indicating pseudo-Class III malocclusion)

7.     Patients should be having healthy gingival and periodontal status

EXCLUSION CRITERIA1.     Craniofacial malformations and/or syndromes

2.     Previous orthopedic/orthodontic treatments.

3.     History of facial trauma

4.     Periodontitis

5.     History of prolonged treatment with systemic steroids and NSAIDs, Systemic diseases including Diabetes mellitus or History of metabolic disorders

6.     Presence of cysts, tumors, and other pathologies

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

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

  • Patients with developing skeletal Class III malocclusion having bilateral jaw discrepancy or combination of maxillary retrognathism and mandibular prognathism will be included in the study Patients in the age group 10 to 14years Angles Class III malocclusion with Anterior and posterior Crossbite Wit’s appraisal of -2.0 mm or less and ANB less than 0 degrees Skeletal maturation CVMI 2 and 3 stage Absence of CO-CR discrepancy (indicating pseudo-Class III malocclusion) Patients should be having healthy gingival and periodontal status.

排除标准

  • Craniofacial malformations and syndromes Previous orthopedic or orthodontic treatments History of facial trauma Periodontitis History of prolonged treatment with systemic steroids and NSAIDs Systemic diseases including Diabetes mellitus or History of metabolic disorders Presence of cysts tumors and other pathologies Patients with disorders affecting bone healing metabolism and turn over.

结局指标

主要结局

To evaluate and compare the psychological effects using PIDAQ and skeletal dental, soft tissue changes using cephalometric in patients with developing class III malocclusion undergoing modified SEC III protocol at two-time intervals: pre-treatment and post treatment

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 SEC III appliance have concluded

次要结局

  • Duration taken for the correction of class III malocclusion by modified SEC III appliance(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]
责任方
Principal Investigator
主要研究者

Mohasin M

Mes Dental College

研究点 (1)

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