Malocclusion, Angle Class II
Conditions
Keywords
quality of life
Brief summary
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
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.
Interventions
DEVICETwin Block
functional appliances for the stimulation of the mandibular growth
DEVICESander bite jumping appliance
functional appliances for the stimulation of the mandibular growth
Sponsors
Clinical Hospital Center Rijeka
University of Rijeka
Visnja Katic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* distal molar occlusion, overjet \>5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4
Exclusion criteria
* mental retardation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms | baseline | 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 |
| Overjet | baseline | sagittal distance between upper and lower anterior teeth measured in mm |
| subscale functional limitations of CPQ 11-14 SF16 | baseline | 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 |
| subscale emotional well-being of CPQ 11-14 SF16 | baseline | 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 |
| subscale social well-being of CPQ 11-14 SF 16 | baseline | 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 |
| Self-perceived satisfaction with dental appearance | baseline | rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance |
| Self-perceived treatment need | baseline | rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need |
| change in overjet | change from baseline to one year of appliance wear | sagittal distance between upper and lower anterior teeth measured in mm |
| overall score of CPQ 11-14 SF 16 and SF8 | baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| family conflict subscale of FIS | baseline | 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 |
| financial burden subscale of FIS | baseline | 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 |
| change in functional limitations of CPQ | change from baseline to one year of appliance wear | 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 in emotional well-being of CPQ | change from baseline to one year of appliance wear | 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 in oral symptoms of CPQ 11-14 SF16 | change from baseline to one year of appliance wear | 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 in overall score of CPQ SF8 | change from baseline to one year of appliance wear | 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 |
| validation of CPQ 11-14 in Croatia | one year | 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 |
| validation of P CPQ in Croatia | one year | 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 |
| validation of FIS in Croatia | one year | 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 |
| change in social well-being of CPQ | change from baseline to one year of appliance wear | 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 |
| overall score of FIS | baseline | 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 |
| Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms | baseline | 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 |
| P CPQ, subscale functional limitations | baseline | 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 |
| P CPQ, subscale emotional well-being | baseline | 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 |
| P CPQ, subscale social well-being | baseline | 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 |
| overall score of P CPQ | baseline | 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 |
| parental/family activity subscale of Family Impact Scale (FIS) questionnaire | baseline | 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 |
| parental emotions subscale of FIS | baseline | 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 |
Countries
Croatia
Outcome results
None listed