A Phase 3 interventional study of active metal appliance and active esthetic appliance in Malocclusion, sponsored by University of Rijeka. Status unknown at 1 site in Croatia. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by University of Rijeka · Phase 3, Interventional, and Treatment
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.
The aim is to analyze:
469 studies on the registry are indexed under Malocclusion; 91 are open to participants now.
This study's planned enrollment of 120 is above the median of 36 across 383 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →University of Rijeka is the lead sponsor of 21 studies on the registry; 7 are open to participants now.
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- 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
fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
Device: active metal appliance · Combination Product: retention fixed appliance
fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer
Device: active esthetic appliance · Combination Product: retention fixed appliance
fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
Device: active metal appliance · Combination Product: retention removable appliance
fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer
Device: active esthetic appliance · Combination Product: retention removable appliance
fixed metal labial orthodontic appliance MBT 0.022'' slot
fixed ceramic labial orthodontic appliance MBT 0.022'' slot
fixed lingual metal retention appliance
removable clear termoplastic retention appliance
irregularity of teeth
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)
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
Time frame: 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
Time frame: 48 months (start, end of treatment, 1 year retention, 2 years retention)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 months (start, 3 months, 2 years, 1 year retention, 2 years retention)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Jan 2026, 50 months after the start.
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This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Rijeka