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

Primary Purpose

Malocclusion, Angle Class II

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Twin Block
Sander bite jumping appliance
Sponsored by
Visnja Katic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II focused on measuring quality of life

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • mental retardation

Sites / Locations

  • University of Rijeka, Faculty of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Twin Block

Sander

Control

Arm Description

Twin Block functional appliance

Sander bite jumping appliance

no intervention

Outcomes

Primary Outcome Measures

Overjet
sagittal distance between upper and lower anterior teeth measured in mm
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
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
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
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
Self-perceived satisfaction with dental appearance
rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance
Self-perceived treatment need
rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need
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
change in overjet
sagittal distance between upper and lower anterior teeth measured in mm

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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 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 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 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 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
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
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
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

Full Information

First Posted
February 21, 2018
Last Updated
May 20, 2022
Sponsor
Visnja Katic
Collaborators
Clinical Hospital Center Rijeka, University of Rijeka
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1. Study Identification

Unique Protocol Identification Number
NCT03455634
Brief Title
Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
Acronym
PONCOS
Official Title
Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2015 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Visnja Katic
Collaborators
Clinical Hospital Center Rijeka, University of Rijeka

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II
Keywords
quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twin Block
Arm Type
Active Comparator
Arm Description
Twin Block functional appliance
Arm Title
Sander
Arm Type
Active Comparator
Arm Description
Sander bite jumping appliance
Arm Title
Control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Device
Intervention Name(s)
Twin Block
Intervention Description
functional appliances for the stimulation of the mandibular growth
Intervention Type
Device
Intervention Name(s)
Sander bite jumping appliance
Intervention Description
functional appliances for the stimulation of the mandibular growth
Primary Outcome Measure Information:
Title
Overjet
Description
sagittal distance between upper and lower anterior teeth measured in mm
Time Frame
baseline
Title
Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms
Description
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
Time Frame
baseline
Title
subscale functional limitations of CPQ 11-14 SF16
Description
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
Time Frame
baseline
Title
subscale emotional well-being of CPQ 11-14 SF16
Description
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
Time Frame
baseline
Title
subscale social well-being of CPQ 11-14 SF 16
Description
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
Time Frame
baseline
Title
Self-perceived satisfaction with dental appearance
Description
rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance
Time Frame
baseline
Title
Self-perceived treatment need
Description
rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need
Time Frame
baseline
Title
overall score of CPQ 11-14 SF 16 and SF8
Description
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
Time Frame
baseline
Title
change in overjet
Description
sagittal distance between upper and lower anterior teeth measured in mm
Time Frame
change from baseline to one year of appliance wear
Secondary Outcome Measure Information:
Title
Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms
Description
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
Time Frame
baseline
Title
P CPQ, subscale functional limitations
Description
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
Time Frame
baseline
Title
P CPQ, subscale emotional well-being
Description
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
Time Frame
baseline
Title
P CPQ, subscale social well-being
Description
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
Time Frame
baseline
Title
overall score of P CPQ
Description
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
Time Frame
baseline
Title
parental/family activity subscale of Family Impact Scale (FIS) questionnaire
Description
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
Time Frame
baseline
Title
parental emotions subscale of FIS
Description
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
Time Frame
baseline
Title
family conflict subscale of FIS
Description
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
Time Frame
baseline
Title
financial burden subscale of FIS
Description
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
Time Frame
baseline
Title
overall score of FIS
Description
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
Time Frame
baseline
Title
change in oral symptoms of CPQ 11-14 SF16
Description
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
Time Frame
change from baseline to one year of appliance wear
Title
change in functional limitations of CPQ
Description
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
Time Frame
change from baseline to one year of appliance wear
Title
change in emotional well-being of CPQ
Description
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
Time Frame
change from baseline to one year of appliance wear
Title
change in social well-being of CPQ
Description
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
Time Frame
change from baseline to one year of appliance wear
Title
change in overall score of CPQ SF8
Description
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
Time Frame
change from baseline to one year of appliance wear
Title
validation of CPQ 11-14 in Croatia
Description
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
Time Frame
one year
Title
validation of P CPQ in Croatia
Description
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
Time Frame
one year
Title
validation of FIS in Croatia
Description
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: distal molar occlusion, overjet >5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4 Exclusion Criteria: mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stjepan Spalj
Organizational Affiliation
University of Rijeka Faculty of Dental Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University of Rijeka, Faculty of Dental Medicine
City
Rijeka
State/Province
Primorsko-goranska County
ZIP/Postal Code
HR-51000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31444594
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.
Results Reference
result
PubMed Identifier
31118532
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
Citation
Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.
Results Reference
result
PubMed Identifier
34402117
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
Citation
Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.
Results Reference
result
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.
Results Reference
result

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Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success

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