Clinical trial NCT05398328: Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
Official title: Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Malocclusion
Keywords: malocclusion
personality trait
quality of life
Lead sponsor: University of Rijeka
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: irregularity of teeth
timeFrame: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
measure: patient reported impacts of malocclusion
timeFrame: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
measure: big five personality traits
timeFrame: 48 months (start, end of treatment, 1 year retention, 2 years retention)
Secondary outcomes:
measure: normative orthodontic treatment need
timeFrame: 48 months (start, end of treatment, 1 year retention, 2 years retention)
measure: esthetic treatment need
timeFrame: 48 months (start, end of treatment, 1 year retention, 2 years retention)
measure: retainer failure
timeFrame: 24 months
measure: limitations of jaw function
timeFrame: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
measure: self-esteem
timeFrame: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
measure: body image
timeFrame: 48 months (start, end of treatment, 1 year retention, 2 years retention)
measure: perfectionism
timeFrame: 48 months (start, end of treatment, 1 year retention, 2 years retention)
measure: psychosocial imapcts of dental esthetics
timeFrame: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
measure: wite spot lesions of enamel
timeFrame: 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
measure: oral hygiene
timeFrame: 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
measure: extent of gingivitis
timeFrame: 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
measure: gingival enlargement
timeFrame: 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University of Rijeka, Faculty of Dental Medicine
Study officials:
affiliation: Sveuciliste u Rijeci
name: Stjepan Spalj, PhD
role: PRINCIPAL_INVESTIGATOR
References: