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MalocclusionPhase 3OrthoPersNCT05398328

Effect of Personality Traits on Reporting Outcomes of Orthodontic Treatment

A Phase 3 study testing active metal appliance, active esthetic appliance and retention fixed appliance in people with Malocclusion, run by University of Rijeka at 1 site in Croatia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Malocclusion
What is being tested?
active metal appliance, active esthetic appliance and retention fixed appliance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteCroatia
Study dates
1 Nov 2021to 1 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • University of Rijeka, Faculty of Dental Medicine

    Rijeka, 51000

Other trials in Croatia

About this study

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.

Read the 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
Conditions
Malocclusion
Being tested
active metal appliance, active esthetic appliance, retention fixed appliance, retention removable appliance
Keywords
malocclusion, personality trait, quality of life
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active metal applianceDevice

    fixed metal labial orthodontic appliance MBT 0.022'' slot

  • active esthetic applianceDevice

    fixed ceramic labial orthodontic appliance MBT 0.022'' slot

  • retention fixed applianceCombination product

    fixed lingual metal retention appliance

  • retention removable applianceCombination product

    removable clear termoplastic retention appliance

Study groups in NCT05398328
Study groupRoleWhat they receive
metal appliance + fixed retainerActive comparatorfixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
Receives: Device: active metal appliance; Combination Product: retention fixed appliance
esthetic appliance + fixed retainerExperimentalfixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
Receives: Device: active esthetic appliance; Combination Product: retention fixed appliance
metal appliance + removable retainerActive comparatorfixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
Receives: Device: active metal appliance; Combination Product: retention removable appliance
esthetic appliance + removable retainerExperimentalfixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
Receives: Device: active esthetic appliance; Combination Product: retention removable appliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. irregularity of teeth

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

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

  2. 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

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

  3. 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

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

Secondary outcomes (12)

  1. 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

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

  2. esthetic treatment need

    assessed by using Index of Orthodontic Treatment Need - Aesthetic Component with 10 grades, range 1=no need - 10=very great need

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

  3. retainer failure

    number of railures of retainer in retention phase, nigher number indicates worse outcome

    Measured: 24 months

  4. 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

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

  5. 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

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

  6. body image

    4 items on 5-point scale (1=not at all-5=very much), total score 4-20, higher score indicates better outcome

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

  7. perfectionism

    35 items on 5-point scale (1=completely disagree-5=completely agree), range 29 - 145, higher score indicates better outcome

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

  8. 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

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

  9. wite spot lesions of enamel

    number of teeth with enamel defects, scale 0-32, higher number means worse outcome

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

  10. 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

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

  11. extent of gingivitis

    Full Mouth Bleeding Score on a scale 0-100%, higher percentage means worse outcome

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

  12. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start1 Nov 2021
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398328
Sponsor's protocol ID
2107-57-006-20-1
Acronym
OrthoPers
Status last verified
Dec 2023
First submitted
23 May 2022
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing active metal appliance, active esthetic appliance and retention fixed appliance in people with Malocclusion, run by University of Rijeka at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

irregularity of teeth (time frame: 48 months (start, 3 months, 1 year, 2 years, 1 year retention, 2 years retention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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