Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

Conditions
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Malocclusion

Intervention / Treatment
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* Device: active metal appliance
* Device: active esthetic appliance
* Combination Product: retention fixed appliance
* Combination Product: retention removable appliance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metal appliance + fixed retainer<br>fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer | Device: active metal appliance<br>* fixed metal labial orthodontic appliance MBT 0.022'' slot<br>Combination Product: retention fixed appliance<br>* fixed lingual metal retention appliance<br>|
| Experimental: esthetic appliance + fixed retainer<br>fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer | Device: active esthetic appliance<br>* fixed ceramic labial orthodontic appliance MBT 0.022'' slot<br>Combination Product: retention fixed appliance<br>* fixed lingual metal retention appliance<br>|
| Active Comparator: metal appliance + removable retainer<br>fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer | Device: active metal appliance<br>* fixed metal labial orthodontic appliance MBT 0.022'' slot<br>Combination Product: retention removable appliance<br>* removable clear termoplastic retention appliance<br>|
| Experimental: esthetic appliance + removable retainer<br>fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer | Device: active esthetic appliance<br>* fixed ceramic labial orthodontic appliance MBT 0.022'' slot<br>Combination Product: retention removable appliance<br>* removable clear termoplastic retention appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| irregularity of teeth | Little Irregularity Index - sum of displacement of contact points of frontal teeth (range 0-10 mm), higher score mean worse outcome | 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) | 
| patient reported impacts of malocclusion | Malocclusion Impact Questionnaire with 17 aspects, each on 3-point scale (summary score on scale 0-51), higher score mean worse outcome | 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) | 
| big five personality traits | 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 | 48 months (start, end of treatment, 1 year retention, 2 years retention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normative orthodontic treatment need | clinically assessed by using Index of Orthodontic Treatment Need - Dental Health Component with 5 grades, range 1=no/minor need - 5=very great need | 48 months (start, end of treatment, 1 year retention, 2 years retention) | 
| esthetic treatment need | assessed by using Index of Orthodontic Treatment Need - Aesthetic Component with 10 grades, range 1=no need - 10=very great need | 48 months (start, end of treatment, 1 year retention, 2 years retention) | 
| retainer failure | number of railures of retainer in retention phase, nigher number indicates worse outcome | 24 months | 
| limitations of jaw function | Jaw Function Limitation Scale with 6 items on 11-point scale (0=no limitation-10=extreme limitation), average score, higher score indicates worse outcome | 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) | 
| self-esteem | 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 | 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) | 
| body image | 4 items on 5-point scale (1=not at all-5=very much), total score 4-20, higher score indicates better outcome | 48 months (start, end of treatment, 1 year retention, 2 years retention) | 
| perfectionism | 35 items on 5-point scale (1=completely disagree-5=completely agree), range 29 - 145, higher score indicates better outcome | 48 months (start, end of treatment, 1 year retention, 2 years retention) | 
| psychosocial imapcts of dental esthetics | 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 | 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention) | 
| wite spot lesions of enamel | number of teeth with enamel defects, scale 0-32, higher number means worse outcome | 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) | 
| oral hygiene | 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 | 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) | 
| extent of gingivitis | Full Mouth Bleeding Score on a scale 0-100%, higher percentage means worse outcome | 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) | 
| gingival enlargement | 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 | 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malocclusion, personality trait, quality of life