Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success

Malocclusion, Angle Class II Clinical Trial

— PONCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455634
• Other study ID #: 2170-24-01-15-2
• Secondary ID: 2170-29-02/1-14-
• Status: Completed
• Phase: N/A
• Start date: February 9, 2015
• Est. completion date: May 17, 2022

Study information

• Verified date: May 2022
• Source: University of Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 17, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• mental retardation

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Twin Block
functional appliances for the stimulation of the mandibular growth
• Sander bite jumping appliance
functional appliances for the stimulation of the mandibular growth

Locations

Country	Name	City	State
Croatia	University of Rijeka, Faculty of Dental Medicine	Rijeka	Primorsko-goranska County

Sponsors (3)

Lead Sponsor	Collaborator
Visnja Katic	Clinical Hospital Center Rijeka, University of Rijeka

Country where clinical trial is conducted

Croatia, 

References & Publications (11)

Acev DP, Brumini M, Šlaj M, Katic V, Špalj 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. — View Citation

Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.

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. E — View 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;54:210:21

Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.

Marijanovic M, Uhac 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.

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.

Uhac 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.

Uhac M, Zibar Belašic T, Perkovic V, Matijevic M, Špalj S. Orthodontic treatment demand in young adolescents - comparison of parents and their children. 7. Medunarodni kongres Stomatološkog fakulteta Sveucilišta u Zagrebu. Acta Stomatologica Croatica. Rov

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 N — View 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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overjet	sagittal distance between upper and lower anterior teeth measured in mm	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Self-perceived treatment need	rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need	baseline
Primary	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
Primary	change in overjet	sagittal distance between upper and lower anterior teeth measured in mm	change from baseline to one year of appliance wear
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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