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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malocclusion
• Intervention / Treatment: Device: active metal appliance; Combination product: retention fixed appliance; Device: active esthetic appliance; Combination product: retention removable appliance

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Croatia
  • Rijeka, Croatia, 51000
    • University of Rijeka, Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: metal appliance + fixed retainer; fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer	Device: active metal appliance; fixed metal labial orthodontic appliance MBT 0.022'' slot; Combination product: retention fixed appliance; fixed lingual metal retention appliance
Experimental: esthetic appliance + fixed retainer; fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer	Combination product: retention fixed appliance; fixed lingual metal retention appliance; Device: active esthetic appliance; fixed ceramic labial orthodontic appliance MBT 0.022'' slot
Active Comparator: metal appliance + removable retainer; fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer	Device: active metal appliance; fixed metal labial orthodontic appliance MBT 0.022'' slot; Combination product: retention removable appliance; removable clear termoplastic retention appliance
Experimental: esthetic appliance + removable retainer; fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer	Device: active esthetic appliance; fixed ceramic labial orthodontic appliance MBT 0.022'' slot; Combination product: retention removable appliance; removable clear termoplastic retention appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
normative orthodontic treatment need	clinically assessed by using Index of Orthodontic Treatment Need - Dental Health Component with 5 grades, range 1=no/minor need - 5=very great need	48 months (start, end of treatment, 1 year retention, 2 years retention)
esthetic treatment need	assessed by using Index of Orthodontic Treatment Need - Aesthetic Component with 10 grades, range 1=no need - 10=very great need	48 months (start, end of treatment, 1 year retention, 2 years retention)
retainer failure	number of railures of retainer in retention phase, nigher number indicates worse outcome	24 months
limitations of jaw function	Jaw Function Limitation Scale with 6 items on 11-point scale (0=no limitation-10=extreme limitation), average score, higher score indicates worse outcome	48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
self-esteem	Rosenberg Self-Esteem Scale with 10 items on 5-point scale (1=not at all-5=very much), summary score on scale 5-50, higher score indicates better outcome	48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
body image	4 items on 5-point scale (1=not at all-5=very much), total score 4-20, higher score indicates better outcome	48 months (start, end of treatment, 1 year retention, 2 years retention)
perfectionism	35 items on 5-point scale (1=completely disagree-5=completely agree), range 29 - 145, higher score indicates better outcome	48 months (start, end of treatment, 1 year retention, 2 years retention)
psychosocial imapcts of dental esthetics	23 items on 5-point scale (0=not at all-4=very much), grouped in 4 dimensions - aesthetic concern (range 0-12), dental self-confidence (range 0-24), social influence (range 0-32), psychological influence (range 0-24)), higher score means worse outcome for psychological influence, social influence and aesthetic concern, while in dental self-confidence higher score indicates better outcome	48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
wite spot lesions of enamel	number of teeth with enamel defects, scale 0-32, higher number means worse outcome	48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
oral hygiene	Silness-Loe index and Williams modification for subjects in orthodontic treatment on a scale from 0=no biofilm to 3=a continuous line greater than 1mm, mean of all measurement site is used, range 0-3, higher score means worse outcome	48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
extent of gingivitis	Full Mouth Bleeding Score on a scale 0-100%, higher percentage means worse outcome	48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
gingival enlargement	Seymour index (thickness (scale 0=normal-2=thickening >=3mm) + proportion of tooth crown coverage (scale 0=normal-3=papilla involving .2/3 of adjacent tooth crown half) on frontal teeth vestibular and oral in both jaws; scale 0-100), higher score means worse outcome	48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)

Collaborators and Investigators

• Sponsor: University of Rijeka
• Investigators: Principal Investigator: Stjepan Spalj, PhD, Sveuciliste u Rijeci

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; malocclusion; personality trait
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 2107-57-006-20-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No