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

Primary Purpose

Malocclusion

Status
Recruiting
Phase
Phase 3
Locations
Croatia
Study Type
Interventional
Intervention
active metal appliance
active esthetic appliance
retention fixed appliance
retention removable appliance
Sponsored by
University of Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring malocclusion, personality trait, quality of life

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Rijeka, Faculty of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

metal appliance + fixed retainer

esthetic appliance + fixed retainer

metal appliance + removable retainer

esthetic appliance + removable retainer

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

irregularity of teeth
Little Irregularity Index - sum of displacement of contact points of frontal teeth (range 0-10 mm), higher score mean worse outcome
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
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

Secondary Outcome Measures

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
esthetic treatment need
assessed by using Index of Orthodontic Treatment Need - Aesthetic Component with 10 grades, range 1=no need - 10=very great need
retainer failure
number of railures of retainer in retention phase, nigher number indicates worse outcome
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
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
body image
4 items on 5-point scale (1=not at all-5=very much), total score 4-20, higher score indicates better outcome
perfectionism
35 items on 5-point scale (1=completely disagree-5=completely agree), range 29 - 145, higher score indicates better outcome
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
wite spot lesions of enamel
number of teeth with enamel defects, scale 0-32, higher number means worse outcome
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
extent of gingivitis
Full Mouth Bleeding Score on a scale 0-100%, higher percentage means worse outcome
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

Full Information

First Posted
May 23, 2022
Last Updated
May 26, 2022
Sponsor
University of Rijeka
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1. Study Identification

Unique Protocol Identification Number
NCT05398328
Brief Title
Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
Acronym
OrthoPers
Official Title
Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rijeka

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The aim is to analyze: the extent to which the type of device (metal / aesthetic) affects changes in quality of life (QoL) whether the change in QoL is influenced by personality traits during therapy long-term change in QoL and personality traits (before therapy, during, at the end and in retention for 2 years) whether long-term QoL change is influenced by personality traits dependence of relapse (incidence and intensity) on the type of retention appliance change in QoL and personality trait depending on relapse whether the change in QoL due to relapse is influenced by personality traits

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
malocclusion, personality trait, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
statistician will not be aware of group affiliation
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metal appliance + fixed retainer
Arm Type
Active Comparator
Arm Description
fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
Arm Title
esthetic appliance + fixed retainer
Arm Type
Experimental
Arm Description
fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
Arm Title
metal appliance + removable retainer
Arm Type
Active Comparator
Arm Description
fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
Arm Title
esthetic appliance + removable retainer
Arm Type
Experimental
Arm Description
fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
Intervention Type
Device
Intervention Name(s)
active metal appliance
Intervention Description
fixed metal labial orthodontic appliance MBT 0.022'' slot
Intervention Type
Device
Intervention Name(s)
active esthetic appliance
Intervention Description
fixed ceramic labial orthodontic appliance MBT 0.022'' slot
Intervention Type
Combination Product
Intervention Name(s)
retention fixed appliance
Intervention Description
fixed lingual metal retention appliance
Intervention Type
Combination Product
Intervention Name(s)
retention removable appliance
Intervention Description
removable clear termoplastic retention appliance
Primary Outcome Measure Information:
Title
irregularity of teeth
Description
Little Irregularity Index - sum of displacement of contact points of frontal teeth (range 0-10 mm), higher score mean worse outcome
Time Frame
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Title
patient reported impacts of malocclusion
Description
Malocclusion Impact Questionnaire with 17 aspects, each on 3-point scale (summary score on scale 0-51), higher score mean worse outcome
Time Frame
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Title
big five personality traits
Description
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
Time Frame
48 months (start, end of treatment, 1 year retention, 2 years retention)
Secondary Outcome Measure Information:
Title
normative orthodontic treatment need
Description
clinically assessed by using Index of Orthodontic Treatment Need - Dental Health Component with 5 grades, range 1=no/minor need - 5=very great need
Time Frame
48 months (start, end of treatment, 1 year retention, 2 years retention)
Title
esthetic treatment need
Description
assessed by using Index of Orthodontic Treatment Need - Aesthetic Component with 10 grades, range 1=no need - 10=very great need
Time Frame
48 months (start, end of treatment, 1 year retention, 2 years retention)
Title
retainer failure
Description
number of railures of retainer in retention phase, nigher number indicates worse outcome
Time Frame
24 months
Title
limitations of jaw function
Description
Jaw Function Limitation Scale with 6 items on 11-point scale (0=no limitation-10=extreme limitation), average score, higher score indicates worse outcome
Time Frame
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Title
self-esteem
Description
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
Time Frame
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Title
body image
Description
4 items on 5-point scale (1=not at all-5=very much), total score 4-20, higher score indicates better outcome
Time Frame
48 months (start, end of treatment, 1 year retention, 2 years retention)
Title
perfectionism
Description
35 items on 5-point scale (1=completely disagree-5=completely agree), range 29 - 145, higher score indicates better outcome
Time Frame
48 months (start, end of treatment, 1 year retention, 2 years retention)
Title
psychosocial imapcts of dental esthetics
Description
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
Time Frame
48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)
Title
wite spot lesions of enamel
Description
number of teeth with enamel defects, scale 0-32, higher number means worse outcome
Time Frame
48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
Title
oral hygiene
Description
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
Time Frame
48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
Title
extent of gingivitis
Description
Full Mouth Bleeding Score on a scale 0-100%, higher percentage means worse outcome
Time Frame
48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
Title
gingival enlargement
Description
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
Time Frame
48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stjepan Spalj, PhD
Phone
+385916119853
Email
stjepan.spalj@fdmri.uniri.hr
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Zigante, PhD
Phone
+385981306006
Email
mzigante0@gmail.com
Facility Information:
Facility Name
University of Rijeka, Faculty of Dental Medicine
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stjepan Spalj, PhD
Phone
385916119853
Email
stjepan.spalj@fdmri.uniri.hr
First Name & Middle Initial & Last Name & Degree
Martina Zigante, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared on reasonable request.
IPD Sharing Time Frame
after 48 months, one year

Learn more about this trial

Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

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