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OpenTrials
Completed

NCT Number: NCT03455634

Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success

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.

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Key information

Conditions

Malocclusion, Angle Class II Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rijeka, Faculty of Dental Medicine

Rijeka, Primorsko-goranska County, HR-51000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • mental retardation

Treatment and study plan

Twin Block

Device

functional appliances for the stimulation of the mandibular growth

Sander bite jumping appliance

Device

functional appliances for the stimulation of the mandibular growth

Primary outcomes

  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 SF16) , subscale measuring oral symptoms

    Time frame: baseline

    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

  3. subscale functional limitations of CPQ 11-14 SF16

    Time frame: baseline

    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

  4. subscale emotional well-being of CPQ 11-14 SF16

    Time frame: baseline

    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

  5. subscale social well-being of CPQ 11-14 SF 16

    Time frame: baseline

    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

  6. Self-perceived satisfaction with dental appearance

    Time frame: baseline

    rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance

  7. Self-perceived treatment need

    Time frame: baseline

    rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need

  8. overall score of CPQ 11-14 SF 16 and SF8

    Time frame: baseline

    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

  9. 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 outcomes

  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 0-28, 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 0-32, 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 SF16

    Time frame: change from baseline to one year of appliance wear

    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, 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

  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 0-16, 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

  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 0-16, 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

  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 0-16, 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

  15. change in overall score of CPQ SF8

    Time frame: change from baseline to one year of appliance wear

    CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32, 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

  16. validation of CPQ 11-14 in Croatia

    Time frame: one year

    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

  17. validation of P CPQ in Croatia

    Time frame: one year

    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

  18. validation of FIS in Croatia

    Time frame: one year

    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

Sponsors and collaborators

Lead sponsor

Visnja Katic

Other

Collaborators

  • Clinical Hospital Center Rijeka
  • University of Rijeka

Registry information

Official study title

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

Acronym: PONCOS

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2018
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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