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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metal appliance + fixed retainer | Active Comparator | fixed metal appliance MBT 0.022'' slot in active phase followed by bonded wire retainer |
|
| esthetic appliance + fixed retainer | Experimental | fixed ceramic appliance MBT 0.022'' slot in active phase followed by bonded wire retainer |
|
| metal appliance + removable retainer | Active Comparator | fixed metal appliance MBT 0.022'' slot followed by removable clear termoplastic retainer |
|
| esthetic appliance + removable retainer | Experimental | fixed ceramic appliance MBT 0.022'' slot followed by removable clear termoplastic retainer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active metal appliance | Device | fixed metal labial orthodontic appliance MBT 0.022'' slot |
|
| 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) |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Stjepan Spalj, PhD | Sveuciliste u Rijeci | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rijeka, Faculty of Dental Medicine | Rijeka | 51000 | Croatia |
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.
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 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.
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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statistician will not be aware of group affiliation
| active esthetic appliance | Device | fixed ceramic labial orthodontic appliance MBT 0.022'' slot |
|
| retention fixed appliance | Combination Product | fixed lingual metal retention appliance |
|
| retention removable appliance | Combination Product | removable clear termoplastic retention appliance |
|
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) |