Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- irregularity of teeth
研究概览
简要总结
The study will monitor changes induced by orthodontic treatment and in the retention period, two years after the end of orthodontic treatment. The alignment of teeth, hygiene and gingiva will be assessed. Efficiency of two types of fixed appliances in active phase will be compared - esthetic and metal. Efficiency of two types of retention appliances in retention phase will be compared - fixed and removable.
The benefits of orthodontic treatment to be studied are aesthetic concerns, dental self-confidence, self-esteem, social contacts, psychological influences, and chewing limitation. The stability of personality traits, body image and perfectionism will also be analyzed, as well as the extent to which these dimensions modify the reporting of psychosocial effects of malocclusion treatment.
详细描述
The aim is to analyze:
- the extent to which the type of device (metal / aesthetic) affects changes in quality of life (QoL)
- whether the change in QoL is influenced by personality traits during therapy
- long-term change in QoL and personality traits (before therapy, during, at the end and in retention for 2 years)
- whether long-term QoL change is influenced by personality traits
- dependence of relapse (incidence and intensity) on the type of retention appliance
- change in QoL and personality trait depending on relapse
- whether the change in QoL due to relapse is influenced by personality traits
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
statistician will not be aware of group affiliation
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades >=3)
排除标准
- •neurodevelopmental disorders, intellectual disability, oligodontia, congenital craniofacial anomalies, orofacial clefts
研究组 & 干预措施
metal appliance + removable retainer
fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
干预措施: retention removable appliance (Combination Product)
esthetic appliance + removable retainer
fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
干预措施: active esthetic appliance (Device)
esthetic appliance + removable retainer
fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
干预措施: retention removable appliance (Combination Product)
metal appliance + fixed retainer
fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
干预措施: active metal appliance (Device)
metal appliance + fixed retainer
fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
干预措施: retention fixed appliance (Combination Product)
esthetic appliance + fixed retainer
fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
干预措施: active esthetic appliance (Device)
esthetic appliance + fixed retainer
fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
干预措施: retention fixed appliance (Combination Product)
metal appliance + removable retainer
fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
干预措施: active metal appliance (Device)
结局指标
主要结局
irregularity of teeth
时间窗: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Little Irregularity Index - sum of displacement of contact points of frontal teeth (range 0-10 mm), higher score mean worse outcome
patient reported impacts of malocclusion
时间窗: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Malocclusion Impact Questionnaire with 17 aspects, each on 3-point scale (summary score on scale 0-51), higher score mean worse outcome
big five personality traits
时间窗: 48 months (start, end of treatment, 1 year retention, 2 years retention)
Big Five Inventory with 44 statements, each on 5-point scale, grouped into 5 traits: (extroversion (range 8-40), agreeableness (range 9-45), openness (range 10-50), conscientiousness (range 9-45) and neuroticism (range 8-40). higher score mean worse outcome
次要结局
- normative orthodontic treatment need(48 months (start, end of treatment, 1 year retention, 2 years retention))
- perfectionism(48 months (start, end of treatment, 1 year retention, 2 years retention))
- wite spot lesions of enamel(48 months (start, 3 months, 2 years, 1 year retention, 2 years retention))
- limitations of jaw function(48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention))
- retainer failure(24 months)
- self-esteem(48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention))
- body image(48 months (start, end of treatment, 1 year retention, 2 years retention))
- psychosocial imapcts of dental esthetics(48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention))
- esthetic treatment need(48 months (start, end of treatment, 1 year retention, 2 years retention))
- oral hygiene(48 months (start, 3 months, 2 years, 1 year retention, 2 years retention))
- extent of gingivitis(48 months (start, 3 months, 2 years, 1 year retention, 2 years retention))
- gingival enlargement(48 months (start, 3 months, 2 years, 1 year retention, 2 years retention))
研究者
Stjepan Spalj
Professor
University of Rijeka