Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success

Study Overview
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Brief Summary
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Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment. Methods: evaluation before, during and at the end of orthodontic treatment. Clinical and diagnostic evaluation of complexity before and at the end of orthodontic treatment, evaluation of awareness of treatment need, impact on social and psychological aspects, functional disturbances, impact of malocclusion on quality of life, social interaction, ability to perform daily activities.

Detailed Description
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Data will include diagnostic measurements on study casts, x-rays, and data from questionnaires given to children and parents. Statistical analyses will explore predictors of treatment success with treatment need, compliance and psycho-social domains.

Official Title
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Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome

Conditions
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Malocclusion, Angle Class II

Intervention / Treatment
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* Device: Twin Block
* Device: Sander bite jumping appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: distal molar occlusion, overjet >5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4 Exclusion Criteria: mental retardation

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Twin Block<br>Twin Block functional appliance | Device: Twin Block<br>* functional appliances for the stimulation of the mandibular growth<br>|
| Active Comparator: Sander<br>Sander bite jumping appliance | Device: Sander bite jumping appliance<br>* functional appliances for the stimulation of the mandibular growth<br>|
| No Intervention: Control<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overjet | sagittal distance between upper and lower anterior teeth measured in mm | baseline | 
| Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of oral symptoms on quality of life | baseline | 
| subscale functional limitations of CPQ 11-14 SF16 | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of functional limitations on quality of life | baseline | 
| subscale emotional well-being of CPQ 11-14 SF16 | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of emotional wee-being on quality of life | baseline | 
| subscale social well-being of CPQ 11-14 SF 16 | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of social well-being on quality of life | baseline | 
| Self-perceived satisfaction with dental appearance | rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance | baseline | 
| Self-perceived treatment need | rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need | baseline | 
| overall score of CPQ 11-14 SF 16 and SF8 | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32 for SF8 and 0-64 for SF16 (sum of all items in short-form 8 and 16 instruments), higher score means higher impact of oral disorders on quality of life | baseline | 
| change in overjet | sagittal distance between upper and lower anterior teeth measured in mm | change from baseline to one year of appliance wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms | P CPQ, answers on 5-point Likert scale (0-4), score range 0-24, higher score means greater impact of children's oral health status on oral symptoms, as perceived by parents / caregivers | baseline | 
| P CPQ, subscale functional limitations | P CPQ, answers on 5-point Likert scale (0-4), score range 0-28, higher score means greater impact of children's oral health status on functional limitations, as perceived by parents / caregivers | baseline | 
| P CPQ, subscale emotional well-being | P CPQ, answers on 5-point Likert scale (0-4), score range 0-32, higher score means greater impact of children's oral health status on emotional well-being, as perceived by parents / caregivers | baseline | 
| P CPQ, subscale social well-being | P CPQ, answers on 5-point Likert scale (0-4), score range 0-40, higher score means greater impact of children's oral health status on social well-being, as perceived by parents / caregivers | baseline | 
| overall score of P CPQ | P CPQ, answers on 5-point Likert scale (0-4), score range 0-124 (sum of subscales), higher score means greater impact of children's oral health status on quality of life, as perceived by parents / caregivers | baseline | 
| parental/family activity subscale of Family Impact Scale (FIS) questionnaire | FIS questionnaire, answers on 5-point Likert scale (0-4), score range 0-20, higher score means greater impact of children's oral health status on parental/family activity, as perceived by parents / caregivers | baseline | 
| parental emotions subscale of FIS | FIS, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of children's oral health status on parental emotions, as perceived by parents / caregivers | baseline | 
| family conflict subscale of FIS | FIS, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of children's oral health status on family conflict, as perceived by parents / caregivers | baseline | 
| financial burden subscale of FIS | FIS, answers on 5-point Likert scale (0-4), score range 0-4, higher score means greater impact of children's oral health status on financial burden, as perceived by parents / caregivers | baseline | 
| overall score of FIS | FIS, answers on 5-point Likert scale (0-4), score range 0-56 (sum of subscales), higher score means greater impact of children's oral health status on family, as perceived by parents / caregivers | baseline | 
| change in oral symptoms of CPQ 11-14 SF16 | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change of oral symptoms on quality of life | change from baseline to one year of appliance wear | 
| change in functional limitations of CPQ | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change in functional limitations on quality of life | change from baseline to one year of appliance wear | 
| change in emotional well-being of CPQ | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change in emotional well-being on quality of life | change from baseline to one year of appliance wear | 
| change in social well-being of CPQ | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change in social well-being on quality of life | change from baseline to one year of appliance wear | 
| change in overall score of CPQ SF8 | CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32, change in sum score from baseline to one year of appliance, higher score means greater impact of change in oral disorders on quality of life | change from baseline to one year of appliance wear | 
| validation of CPQ 11-14 in Croatia | 16 items and 8 items short form questionnaires, answers on 5-point Likert scale (0-4), score range 0-64, higher score means greater impairment of quality of life | one year | 
| validation of P CPQ in Croatia | 31 items, answers on 5-point Likert scale (0-4), score range 0-124, higher score means greater impairment of childrens' quality of life perceived by their parents | one year | 
| validation of FIS in Croatia | 14 items, answers on 5-point Likert scale (0-4), score range 0-56, higher score means greater impairment of children's' quality of life perceived by their parents | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life