Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
- Conditions
- Malocclusion, Angle Class II
- Interventions
- Device: Sander bite jumping applianceDevice: Twin Block
- Registration Number
- NCT03455634
- Lead Sponsor
- Visnja Katic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- distal molar occlusion, overjet >5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4
- mental retardation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sander Sander bite jumping appliance Sander bite jumping appliance Twin Block Twin Block Twin Block functional appliance
- Primary Outcome Measures
Name Time Method 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 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
change in overjet change from baseline to one year of appliance wear sagittal distance between upper and lower anterior teeth measured in mm
Overjet baseline 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
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
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
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
- Secondary Outcome Measures
Name Time Method 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
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 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
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 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
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
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 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
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
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 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
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
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
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
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 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 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
Trial Locations
- Locations (1)
University of Rijeka, Faculty of Dental Medicine
🇭🇷Rijeka, Primorsko-goranska County, Croatia