PONCOS: Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success

• Sponsor: Visnja Katic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03455634
• Collaborator: Clinical Hospital Center Rijeka (Other), University of Rijeka (Other)
• Enrollment: 110
• Location: 1
• Arms: 3
• Actual Duration (Months): 87.2
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malocclusion, Angle Class II	Device: Twin Block; Device: Sander bite jumping appliance	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 110 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: Feb 9, 2015
• Actual Primary Completion Date: Apr 1, 2022
• Actual Study Completion Date: May 17, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overjet [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 [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 [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 [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 [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 [baseline]

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

7. Self-perceived treatment need [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• mental retardation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rijeka, Faculty of Dental Medicine	Rijeka	Primorsko-goranska County	Croatia	HR-51000

Sponsors and Collaborators

• Visnja Katic
• Clinical Hospital Center Rijeka
• University of Rijeka

Investigators

• Study Director: Stjepan Spalj, University of Rijeka Faculty of Dental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Visnja Katic, Post-doc, University of Rijeka
• ClinicalTrials.gov Identifier: NCT03455634
• Other Study ID Numbers: 2170-24-01-15-2; 2170-29-02/1-14-5; 13.06.2.1.53; uniri-biomed-18-22; IP9
• First Posted: Mar 6, 2018
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Visnja Katic, Post-doc, University of Rijeka: quality of life
• Additional relevant MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite

Study Results

No Results Posted as of May 26, 2022