Clinical trial NCT03455634: Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
Official title: Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Keywords: quality of life
Lead sponsor: University of Rijeka
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Center Rijeka
name: University of Rijeka
First posted: 2018-03-06
Enrollment: 110
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* distal molar occlusion, overjet \>5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4

Exclusion Criteria:

* mental retardation

Primary outcomes:
measure: Overjet
timeFrame: baseline
measure: Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms
timeFrame: baseline
measure: subscale functional limitations of CPQ 11-14 SF16
timeFrame: baseline
measure: subscale emotional well-being of CPQ 11-14 SF16
timeFrame: baseline
measure: subscale social well-being of CPQ 11-14 SF 16
timeFrame: baseline
measure: Self-perceived satisfaction with dental appearance
timeFrame: baseline
measure: Self-perceived treatment need
timeFrame: baseline
measure: overall score of CPQ 11-14 SF 16 and SF8
timeFrame: baseline
measure: change in overjet
timeFrame: change from baseline to one year of appliance wear
Secondary outcomes:
measure: Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms
timeFrame: baseline
measure: P CPQ, subscale functional limitations
timeFrame: baseline
measure: P CPQ, subscale emotional well-being
timeFrame: baseline
measure: P CPQ, subscale social well-being
timeFrame: baseline
measure: overall score of P CPQ
timeFrame: baseline
measure: parental/family activity subscale of Family Impact Scale (FIS) questionnaire
timeFrame: baseline
measure: parental emotions subscale of FIS
timeFrame: baseline
measure: family conflict subscale of FIS
timeFrame: baseline
measure: financial burden subscale of FIS
timeFrame: baseline
measure: overall score of FIS
timeFrame: baseline
measure: change in oral symptoms of CPQ 11-14 SF16
timeFrame: change from baseline to one year of appliance wear
measure: change in functional limitations of CPQ
timeFrame: change from baseline to one year of appliance wear
measure: change in emotional well-being of CPQ
timeFrame: change from baseline to one year of appliance wear
measure: change in social well-being of CPQ
timeFrame: change from baseline to one year of appliance wear
measure: change in overall score of CPQ SF8
timeFrame: change from baseline to one year of appliance wear
measure: validation of CPQ 11-14 in Croatia
timeFrame: one year
measure: validation of P CPQ in Croatia
timeFrame: one year
measure: validation of FIS in Croatia
timeFrame: one year
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University of Rijeka, Faculty of Dental Medicine
state: Primorsko-goranska County
Study officials:
affiliation: University of Rijeka Faculty of Dental Medicine
name: Stjepan Spalj
role: STUDY_DIRECTOR
References:
citation: Brumini M, Slaj M, Katic V, Pavlic A, Trinajstic Zrinski M, Spalj S. Parental influence is the most important predictor of child's orthodontic treatment demand in a preadolescent age. Odontology. 2020 Jan;108(1):109-116. doi: 10.1007/s10266-019-00447-1. Epub 2019 Aug 23.
citation: Acev DP, Brumini M, Slaj M, Katic V, Spalj S. Child Perceptions Questionnaire in Croatia: Two Domains for Measuring Oral Health. Acta Stomatol Croat. 2019 Mar;53(1):47-54. doi: 10.15644/asc53/1/5.
citation: Uhac M, Zibar Belasic T, Perkovic V, Zigante M, Spalj S. Validation of the Parental-Caregivers Perception Questionnaire (P-CPQ) in Croatia. Abstract book 6th Congress of School of Dental Medicine, University of Zagreb. Acta Stomatol Croat. 2020;54:210:212.
citation: Brumini M, Uhac M, Zibar Belasic T, Spalj S. Parental attitude and emotional well-being mediate orthodontic treatment demand in adolescents. Abstract book 6th Congress of School of Dental Medicine, University of Zagreb. Acta Stomatol Croat. 2020;54:210:212-3.
citation: Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.
citation: Uhac M, Zibar Belasic T, Perkovic V, Matijevic M, Spalj S. Orthodontic treatment demand in young adolescents - Are parents familiar with their children's desires and reasons? Int J Paediatr Dent. 2022 May;32(3):383-391. doi: 10.1111/ipd.12893. Epub 2021 Nov 28.
citation: Uhač M, Zibar Belašić T, Perković V, Matijević M, Špalj S. Orthodontic treatment demand in young adolescents - comparison of parents and their children. 7. Međunarodni kongres Stomatološkog fakulteta Sveučilišta u Zagrebu. Acta Stomatologica Croatica. Rovinj, Hrvatska, 21.-22.05.2021.
citation: Spalj S, Uhac M, Brumini M. Role of parents in patient compliance during class II division 1 malocclusion. 51st SIDO International Congress on-line. 13-14.11.2020.
citation: Marijanović M, Uhač M, Žigante M, Špalj S. Validation of the Family Impact Scale (FIS) in Croatia. 1. Kongres Fakulteta dentalne medicine u Rijeci. 1. i 2. listopada 2020.
citation: Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.
citation: Uhač M, Žigante M, Špalj S. Early Childhood Oral Health Impact Scale and orthodontics: cross-cultural adaptation in Croatia. 51st SIDO International Congress on-line. 13-14.11.2020.