Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success

NCT03455634 | Completed

• 5 other identifiers: 2170-24-01-15-22170-29-02/1-14-513.06.2.1.53uniri-biomed-18-22IP9
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class II

Keywords

quality of life

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (18)

• Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms

  baseline

• P CPQ, subscale functional limitations

  baseline

• P CPQ, subscale emotional well-being

  baseline

• P CPQ, subscale social well-being

  baseline

• overall score of P CPQ

  baseline

Study Arms (3)

Twin Block

ACTIVE COMPARATOR

Twin Block functional appliance

Device: Twin Block

Sander

ACTIVE COMPARATOR

Sander bite jumping appliance

Device: Sander bite jumping appliance

Control

NO INTERVENTION

no intervention

Interventions

Twin Block DEVICE

functional appliances for the stimulation of the mandibular growth

Twin Block

Sander bite jumping appliance DEVICE

functional appliances for the stimulation of the mandibular growth

Sander

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• mental retardation

Sponsors & Collaborators

• Visnja Katic: lead
• Clinical Hospital Center Rijeka: collaborator
• University of Rijeka: collaborator

Study Sites (1)

University of Rijeka, Faculty of Dental Medicine

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

Location

Related Publications (12)

• 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.

  PMID: 31444594 RESULT

• 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.

  PMID: 31118532 RESULT

• 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.

  RESULT

• 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.

  RESULT

• Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.

  RESULT

• 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.

  PMID: 34402117 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.

  RESULT

• 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.

  RESULT

• Cukaj Ademi H, Zigante M, Premaraj Thyagaseely S, Tudor V, Palomo JM, Spalj S. Mandibular Advancement in Dentofacial Orthopaedics: Effects on Pharyngeal Airway, Dentoskeletal Characteristics and Quality of Life: A Randomised Controlled Trial. Orthod Craniofac Res. 2026 Feb;29(1):122-133. doi: 10.1111/ocr.70056. Epub 2025 Nov 10.

  PMID: 41211711 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Stjepan Spalj

  University of Rijeka Faculty of Dental Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post-doc

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 6, 2018
• Study Start: February 9, 2015
• Primary Completion: April 1, 2022
• Study Completion: May 17, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

CR (1)