Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment (OrthoPers)

University of Rijeka

Status and phase: Active, not recruiting; Phase 3

Conditions: Malocclusion

Treatments: Combination Product: retention fixed appliance; Device: active metal appliance; Combination Product: retention removable appliance; Device: active esthetic appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT05398328

2107-57-006-20-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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120 participants in 4 patient groups

metal appliance + fixed retainer

Active Comparator group

Description:

fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer

Treatment:

Combination Product: retention fixed appliance

Device: active metal appliance

esthetic appliance + fixed retainer

Experimental group

Description:

fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer

Treatment:

Device: active esthetic appliance

Combination Product: retention fixed appliance

metal appliance + removable retainer

Active Comparator group

Description:

fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer

Treatment:

Combination Product: retention removable appliance

Device: active metal appliance

esthetic appliance + removable retainer

Experimental group

Description:

fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer

Treatment:

Device: active esthetic appliance

Combination Product: retention removable appliance