Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

NCT ID: NCT05398328

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2026-03-01

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:

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

Conditions

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Malocclusion

Keywords

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malocclusion personality trait quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
statistician will not be aware of group affiliation

Study Groups

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metal appliance + fixed retainer

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

Group Type ACTIVE_COMPARATOR

active metal appliance

Intervention Type DEVICE

fixed metal labial orthodontic appliance MBT 0.022'' slot

retention fixed appliance

Intervention Type COMBINATION_PRODUCT

fixed lingual metal retention appliance

esthetic appliance + fixed retainer

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

Group Type EXPERIMENTAL

active esthetic appliance

Intervention Type DEVICE

fixed ceramic labial orthodontic appliance MBT 0.022'' slot

retention fixed appliance

Intervention Type COMBINATION_PRODUCT

fixed lingual metal retention appliance

metal appliance + removable retainer

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

Group Type ACTIVE_COMPARATOR

active metal appliance

Intervention Type DEVICE

fixed metal labial orthodontic appliance MBT 0.022'' slot

retention removable appliance

Intervention Type COMBINATION_PRODUCT

removable clear termoplastic retention appliance

esthetic appliance + removable retainer

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

Group Type EXPERIMENTAL

active esthetic appliance

Intervention Type DEVICE

fixed ceramic labial orthodontic appliance MBT 0.022'' slot

retention removable appliance

Intervention Type COMBINATION_PRODUCT

removable clear termoplastic retention appliance

Interventions

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active metal appliance

fixed metal labial orthodontic appliance MBT 0.022'' slot

Intervention Type DEVICE

active esthetic appliance

fixed ceramic labial orthodontic appliance MBT 0.022'' slot

Intervention Type DEVICE

retention fixed appliance

fixed lingual metal retention appliance

Intervention Type COMBINATION_PRODUCT

retention removable appliance

removable clear termoplastic retention appliance

Intervention Type COMBINATION_PRODUCT

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rijeka

OTHER

Sponsor Role lead

Responsible Party

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Stjepan Spalj

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stjepan Spalj, PhD

Role: PRINCIPAL_INVESTIGATOR

Sveuciliste u Rijeci

Locations

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University of Rijeka, Faculty of Dental Medicine

Rijeka, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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2107-57-006-20-1

Identifier Type: -

Identifier Source: org_study_id