Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

Malocclusion Clinical Trial

— OrthoPers  

Official title:

Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05398328
• Other study ID #: 2107-57-006-20-1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 1, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: December 2023
• Source: University of Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• active metal appliance
fixed metal labial orthodontic appliance MBT 0.022'' slot
• active esthetic appliance
fixed ceramic labial orthodontic appliance MBT 0.022'' slot

Combination Product:
• retention fixed appliance
fixed lingual metal retention appliance
• retention removable appliance
removable clear termoplastic retention appliance

Locations

Country	Name	City	State
Croatia	University of Rijeka, Faculty of Dental Medicine	Rijeka

Sponsors (1)

Lead Sponsor	Collaborator
University of Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	retainer failure	number of railures of retainer in retention phase, nigher number indicates worse outcome	24 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)