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

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ClinicalTrials.gov Identifier: NCT03455634
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Clinical Hospital Center Rijeka, Croatia
University of Rijeka, Faculty of Medicine
Information provided by (Responsible Party):
Visnja Katic, University of Rijeka

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.


Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class II Device: Twin Block Device: Sander bite jumping appliance Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome
Actual Study Start Date : February 9, 2015
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
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

No Intervention: Control
no intervention



Primary Outcome Measures :
  1. Overjet [ Time Frame: baseline ]
    sagittal distance between upper and lower anterior teeth measured in mm

  2. Child perception questionnaire age 11-14 (CPQ 11-14) , subscale measuring oral symptoms [ Time Frame: baseline ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-24, higher score means greater impact of oral symptoms on quality of life

  3. subscale functional limitations of CPQ 11-14 [ Time Frame: baseline ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-36, higher score means greater impact of functional limitations on quality of life

  4. subscale emotional well-being of CPQ 11-14 [ Time Frame: baseline ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-36, higher score means greater impact of emotional wee-being on quality of life

  5. subscale social well-being of CPQ 11-14 [ Time Frame: baseline ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-52, higher score means greater impact of social well-being on quality of life

  6. Self-perceived satisfaction with dental appearance [ Time Frame: baseline ]
    questionnaire, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater satisfaction with dental apperance

  7. Self-perceived treatment need [ Time Frame: baseline ]
    questionnaire, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater self-perceived treatment need

  8. Self-perceived treatment demand [ Time Frame: baseline ]
    questionnaire, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater self-perceived treatment demand

  9. overall score of CPQ 11-14 [ Time Frame: baseline ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-148 (sum of subscales), higher score means higher impact of oral disorders on quality of life

  10. change in overjet [ Time Frame: change from baseline to one year of appliance wear ]
    sagittal distance between upper and lower anterior teeth measured in mm


Secondary Outcome Measures :
  1. Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms [ Time Frame: 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

  2. P CPQ, subscale functional limitations [ Time Frame: 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 functional limitations, as perceived by parents / caregivers

  3. P CPQ, subscale emotional well-being [ Time Frame: 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 emotional well-being, as perceived by parents / caregivers

  4. P CPQ, subscale social well-being [ Time Frame: 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

  5. overall score of P CPQ [ Time Frame: 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

  6. parental/family activity subscale of Family Impact Scale (FIS) questionnaire [ Time Frame: 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

  7. parental emotions subscale of FIS [ Time Frame: 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

  8. family conflict subscale of FIS [ Time Frame: 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

  9. financial burden subscale of FIS [ Time Frame: 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

  10. overall score of FIS [ Time Frame: 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

  11. change in oral symptoms of CPQ 11-14 [ Time Frame: change from baseline to one year of appliance wear ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-24, 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

  12. change in functional limitations of CPQ [ Time Frame: change from baseline to one year of appliance wear ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-36, 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

  13. change in emotional well-being of CPQ [ Time Frame: change from baseline to one year of appliance wear ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-36, 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

  14. change in social well-being of CPQ [ Time Frame: change from baseline to one year of appliance wear ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-52, 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

  15. change in overall score of CPQ [ Time Frame: change from baseline to one year of appliance wear ]
    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-148, 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



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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • mental retardation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455634


Contacts
Contact: Visnja Katic +38551345638 visnja.katic@medri.uniri.hr
Contact: Stjepan Spalj +38551345638 stjepan.spalj@medri.uniri.hr

Locations
Croatia
University of Rijeka, Faculty of Medicine Recruiting
Rijeka, Primorsko-goranska County, Croatia, HR-51000
Contact: Visnja Katic       visnja.katic@medri.uniri.hr   
Contact: Stjepan Spalj       stjepan.spalj@medri.uniri.hr   
Sponsors and Collaborators
Visnja Katic
Clinical Hospital Center Rijeka, Croatia
University of Rijeka, Faculty of Medicine
Investigators
Study Director: Stjepan Spalj University of Rijeka, Faculty of Medicine

Responsible Party: Visnja Katic, Post-doc, University of Rijeka
ClinicalTrials.gov Identifier: NCT03455634     History of Changes
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 )
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Visnja Katic, University of Rijeka:
quality of life

Additional relevant MeSH terms:
Malocclusion
Malocclusion, Angle Class II
Overbite
Tooth Diseases
Stomatognathic Diseases