Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
- Conditions
- Malocclusion
- Interventions
- Device: active metal applianceDevice: active esthetic applianceCombination Product: retention removable applianceCombination Product: retention fixed appliance
- Registration Number
- NCT05398328
- Lead Sponsor
- University of Rijeka
- Brief Summary
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.
- Detailed Description
The aim is to analyze:
1. the extent to which the type of device (metal / aesthetic) affects changes in quality of life (QoL)
2. whether the change in QoL is influenced by personality traits during therapy
3. long-term change in QoL and personality traits (before therapy, during, at the end and in retention for 2 years)
4. whether long-term QoL change is influenced by personality traits
5. dependence of relapse (incidence and intensity) on the type of retention appliance
6. change in QoL and personality trait depending on relapse
7. whether the change in QoL due to relapse is influenced by personality traits
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades >=3)
- neurodevelopmental disorders, intellectual disability, oligodontia, congenital craniofacial anomalies, orofacial clefts
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description metal appliance + fixed retainer active metal appliance fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer metal appliance + removable retainer retention removable appliance fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer metal appliance + removable retainer active metal appliance fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer esthetic appliance + removable retainer active esthetic appliance fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer esthetic appliance + fixed retainer active esthetic appliance fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer esthetic appliance + fixed retainer retention fixed appliance fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer esthetic appliance + removable retainer retention removable appliance fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer metal appliance + fixed retainer retention fixed appliance fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
- Primary Outcome Measures
Name Time Method irregularity of teeth 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 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 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
- Secondary Outcome Measures
Name Time Method normative orthodontic treatment need 48 months (start, end of treatment, 1 year retention, 2 years retention) clinically assessed by using Index of Orthodontic Treatment Need - Dental Health Component with 5 grades, range 1=no/minor need - 5=very great need
perfectionism 48 months (start, end of treatment, 1 year retention, 2 years retention) 35 items on 5-point scale (1=completely disagree-5=completely agree), range 29 - 145, higher score indicates better outcome
wite spot lesions of enamel 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) number of teeth with enamel defects, scale 0-32, higher number means worse outcome
retainer failure 24 months number of railures of retainer in retention phase, nigher number indicates worse outcome
limitations of jaw function 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) Jaw Function Limitation Scale with 6 items on 11-point scale (0=no limitation-10=extreme limitation), average score, higher score indicates worse outcome
self-esteem 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) Rosenberg Self-Esteem Scale with 10 items on 5-point scale (1=not at all-5=very much), summary score on scale 5-50, higher score indicates better outcome
body image 48 months (start, end of treatment, 1 year retention, 2 years retention) 4 items on 5-point scale (1=not at all-5=very much), total score 4-20, higher score indicates better outcome
psychosocial imapcts of dental esthetics 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) 23 items on 5-point scale (0=not at all-4=very much), grouped in 4 dimensions - aesthetic concern (range 0-12), dental self-confidence (range 0-24), social influence (range 0-32), psychological influence (range 0-24)), higher score means worse outcome for psychological influence, social influence and aesthetic concern, while in dental self-confidence higher score indicates better outcome
esthetic treatment need 48 months (start, end of treatment, 1 year retention, 2 years retention) assessed by using Index of Orthodontic Treatment Need - Aesthetic Component with 10 grades, range 1=no need - 10=very great need
oral hygiene 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) Silness-Loe index and Williams modification for subjects in orthodontic treatment on a scale from 0=no biofilm to 3=a continuous line greater than 1mm, mean of all measurement site is used, range 0-3, higher score means worse outcome
extent of gingivitis 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) Full Mouth Bleeding Score on a scale 0-100%, higher percentage means worse outcome
gingival enlargement 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) Seymour index (thickness (scale 0=normal-2=thickening \>=3mm) + proportion of tooth crown coverage (scale 0=normal-3=papilla involving .2/3 of adjacent tooth crown half) on frontal teeth vestibular and oral in both jaws; scale 0-100), higher score means worse outcome
Trial Locations
- Locations (1)
University of Rijeka, Faculty of Dental Medicine
ðŸ‡ðŸ‡·Rijeka, Croatia