NCT05398328

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

4.2 years

First QC Date

May 23, 2022

Last Update Submit

December 22, 2023

Conditions

Malocclusion

Keywords

malocclusionpersonality traitquality of life

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (12)

  • normative orthodontic treatment need

    48 months (start, end of treatment, 1 year retention, 2 years retention)

  • esthetic treatment need

    48 months (start, end of treatment, 1 year retention, 2 years retention)

  • retainer failure

    24 months

  • limitations of jaw function

    48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)

  • self-esteem

    48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)

  • +7 more secondary outcomes

Study Arms (4)

metal appliance + fixed retainer

ACTIVE COMPARATOR

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

Device: active metal applianceCombination Product: retention fixed appliance

esthetic appliance + fixed retainer

EXPERIMENTAL

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

Device: active esthetic applianceCombination Product: retention fixed appliance

metal appliance + removable retainer

ACTIVE COMPARATOR

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

Device: active metal applianceCombination Product: retention removable appliance

esthetic appliance + removable retainer

EXPERIMENTAL

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

Device: active esthetic applianceCombination Product: retention removable appliance

Interventions

active metal applianceDEVICE

fixed metal labial orthodontic appliance MBT 0.022'' slot

metal appliance + fixed retainermetal appliance + removable retainer
active esthetic applianceDEVICE

fixed ceramic labial orthodontic appliance MBT 0.022'' slot

esthetic appliance + fixed retaineresthetic appliance + removable retainer
retention fixed applianceCOMBINATION_PRODUCT

fixed lingual metal retention appliance

esthetic appliance + fixed retainermetal appliance + fixed retainer
retention removable applianceCOMBINATION_PRODUCT

removable clear termoplastic retention appliance

esthetic appliance + removable retainermetal appliance + removable retainer

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- malocclusion with moderate or great need for orthodontic treatment (Index of Orthodontic Treatment Need grades \>=3)

You may not qualify if:

  • \- neurodevelopmental disorders, intellectual disability, oligodontia, congenital craniofacial anomalies, orofacial clefts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rijeka, Faculty of Dental Medicine

Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Stjepan Spalj, PhD

    Sveuciliste u Rijeci

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
statistician will not be aware of group affiliation
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 31, 2022

Study Start

November 1, 2021

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Data obtained through this research may be provided to qualified researchers with academic interest in orthodontic treatment. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact princial investigator Stjepan Spalj.

Locations

CR(1)