Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success (PONCOS)

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Device: Twin Block; Device: Sander bite jumping appliance

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Primorsko-goranska County
    • Rijeka, Primorsko-goranska County, Croatia, HR-51000
      • University of Rijeka, Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• mental retardation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Visnja Katic
• Collaborators: University of Rijeka; Clinical Hospital Center Rijeka
• Investigators: Study Director: Stjepan Spalj, University of Rijeka Faculty of Dental Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.
• 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.
• 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.
• 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.
• 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.
• Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2015
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: quality of life
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 2170-24-01-15-2; 2170-29-02/1-14-5 (Other Identifier: Clinical Hospital Center Rijeka, Croatia); 13.06.2.1.53 (Other Grant/Funding Number: University of Rijeka); uniri-biomed-18-22 (Other Grant/Funding Number: University of Rijeka); IP9 (Other Grant/Funding Number: J. J. Strossmayer University of Osijek, Faculy of Dental Medicine and Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED