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临床试验/CTRI/2025/03/083589
CTRI/2025/03/083589尚未招募不适用

Short term assessment of quality of life of patients with skeletal Class II and Class III malocclusion undergoing combined surgical and orthodontic treatment A prospective study

MES Dental College1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月8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
24
试验地点
1
主要终点
Primary outcome will be the assessment of improvement in PIDAQ scores at various stages of treatment

研究概览

简要总结

Short term assessment of quality of life of patients with skeletal Class II and Class III malocclusion undergoing combined surgical and orthodontic treatment – A prospective study.

2.  RATIONALE AND RELEVANCE

Quality of Life (QoL) is defined as an individual’s perception of the position in life in the context of cultural and value systems in which they live and in relation to their personal goals, expectations, standards and concerns (WHOQOL).1 Aesthetics plays a very important role in a patient’s decision for orthodontic treatment, even in cases of clear medical necessity. The motivation for improvement of aesthetics is mainly psychosocial in origin. Physical attractiveness is naturally a major contributor to self-esteem and thus affects one’s overall sense of well-being.

RESEARCH QUESTION

Are there any changes in the psychological status of patients with skeletal Class II and Class III malocclusion undergoing combined surgical and orthodontic treatment before and after orthognathic surgery in Malappuram population?

AIM AND OBJECTIVES

The aim of the study is to evaluate the psychological changes occurring at different clinical time-points in patients undergoing combined surgical-orthodontic treatment.

7 INCLUSION CRITERIA

 1.      Patients with skeletal Class II and III malocclusion who will be selected for combined surgical-orthodontic treatment (regardless of the severity of the skeletal malocclusion) in MES Dental college Perinthalmanna having an IOTN dental health component of Grade 3 and above

2.      Patients in the age group between 18 and 30

3.      Willingness to participate in the study.

 9.8 EXCLUSION CRITERIA

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

2.     Patients with jaw deformity as a sequel to maxillofacial trauma

3.     Presence of chronic diseases

4.     Daily use of anti-depressive medication

5.     Presence of advanced periodontal disease

6.     Surgeries performed from other institutions

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

Those whose legal representatives do not authorize participation in the study

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patients with skeletal Class II and III malocclusion who will be selected for combined surgical-orthodontic treatment (regardless of the severity of the skeletal malocclusion) in MES Dental college Perinthalmanna having an IOTN dental health component of Grade 3 and above Patients in the age group between 18 and 30 Willingness to participate in the study.

排除标准

  • Patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate Patients with jaw deformity as a sequel to maxillofacial trauma Presence of chronic diseases Daily use of anti-depressive medication Presence of advanced periodontal disease Surgeries performed from other institutions Patient with disorders affecting bone healing, metabolism and turn over Those whose legal representatives do not authorize participation in the study.

结局指标

主要结局

Primary outcome will be the assessment of improvement in PIDAQ scores at various stages of treatment

时间窗: T0 Pre-Surgery (1 month prior to Surgery) | T1 1 month after surgery | T2 3 months After surgery

次要结局

  • Secondary outcome will be association these scores with age, gender and marital status(pre-surgery (T0), 1 to 2 weeks after orthognathic surgery (T1), and 3 months after orthognathic surgery (T2).)

研究者

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

Aswathy Chandran

MES Dental College Kerala

研究点 (1)

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