Malocclusion
Conditions
Keywords
malocclusion, personality trait, quality of life
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
Interventions
DEVICEactive metal appliance
fixed metal labial orthodontic appliance MBT 0.022'' slot
DEVICEactive esthetic appliance
fixed ceramic labial orthodontic appliance MBT 0.022'' slot
COMBINATION_PRODUCTretention fixed appliance
fixed lingual metal retention appliance
COMBINATION_PRODUCTretention removable appliance
removable clear termoplastic retention appliance
Sponsors
University of Rijeka
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
statistician will not be aware of group affiliation
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
\- malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades \>=3)
Exclusion criteria
\- neurodevelopmental disorders, intellectual disability, oligodontia, congenital craniofacial anomalies, orofacial clefts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| retainer failure | 24 months | number of railures of retainer in retention phase, nigher number indicates worse outcome |
Countries
Croatia
Outcome results
None listed