Clinical trial
Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
Name
2107-57-006-20-1
Description
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.
Trial arms
Trial start
2021-11-01
Estimated PCD
2026-01-01
Trial end
2026-03-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
active metal appliance
fixed metal labial orthodontic appliance MBT 0.022'' slot
Arms:
metal appliance + fixed retainer, metal appliance + removable retainer
active esthetic appliance
fixed ceramic labial orthodontic appliance MBT 0.022'' slot
Arms:
esthetic appliance + fixed retainer, esthetic appliance + removable retainer
retention fixed appliance
fixed lingual metal retention appliance
Arms:
esthetic appliance + fixed retainer, metal appliance + fixed retainer
retention removable appliance
removable clear termoplastic retention appliance
Arms:
esthetic appliance + removable retainer, metal appliance + removable retainer
Size
120
Primary endpoint
irregularity of teeth
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
patient reported impacts of malocclusion
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
big five personality traits
48 months (start, end of treatment, 1 year retention, 2 years retention)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'statistician will not be aware of group affiliation', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-12-29
1 organization
Organization
University of Rijeka