Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT03455634
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-11', 'releaseDate': '2024-07-14'}], 'estimatedResultsFirstSubmitDate': '2024-07-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overjet', 'timeFrame': 'baseline', 'description': 'sagittal distance between upper and lower anterior teeth measured in mm'}, {'measure': 'Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms', 'timeFrame': 'baseline', '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'}, {'measure': 'subscale functional limitations of CPQ 11-14 SF16', 'timeFrame': 'baseline', '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'}, {'measure': 'subscale emotional well-being of CPQ 11-14 SF16', 'timeFrame': 'baseline', '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'}, {'measure': 'subscale social well-being of CPQ 11-14 SF 16', 'timeFrame': 'baseline', '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'}, {'measure': 'Self-perceived satisfaction with dental appearance', 'timeFrame': 'baseline', 'description': 'rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance'}, {'measure': 'Self-perceived treatment need', 'timeFrame': 'baseline', 'description': 'rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need'}, {'measure': 'overall score of CPQ 11-14 SF 16 and SF8', 'timeFrame': 'baseline', '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'}, {'measure': 'change in overjet', 'timeFrame': 'change from baseline to one year of appliance wear', 'description': 'sagittal distance between upper and lower anterior teeth measured in mm'}], 'secondaryOutcomes': [{'measure': 'Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms', 'timeFrame': 'baseline', '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"}, {'measure': 'P CPQ, subscale functional limitations', 'timeFrame': 'baseline', '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"}, {'measure': 'P CPQ, subscale emotional well-being', 'timeFrame': 'baseline', '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"}, {'measure': 'P CPQ, subscale social well-being', 'timeFrame': 'baseline', '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"}, {'measure': 'overall score of P CPQ', 'timeFrame': 'baseline', '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"}, {'measure': 'parental/family activity subscale of Family Impact Scale (FIS) questionnaire', 'timeFrame': 'baseline', '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"}, {'measure': 'parental emotions subscale of FIS', 'timeFrame': 'baseline', '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"}, {'measure': 'family conflict subscale of FIS', 'timeFrame': 'baseline', '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"}, {'measure': 'financial burden subscale of FIS', 'timeFrame': 'baseline', '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"}, {'measure': 'overall score of FIS', 'timeFrame': 'baseline', '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"}, {'measure': 'change in oral symptoms of CPQ 11-14 SF16', 'timeFrame': 'change from baseline to one year of appliance wear', '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'}, {'measure': 'change in functional limitations of CPQ', 'timeFrame': 'change from baseline to one year of appliance wear', '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'}, {'measure': 'change in emotional well-being of CPQ', 'timeFrame': 'change from baseline to one year of appliance wear', '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'}, {'measure': 'change in social well-being of CPQ', 'timeFrame': 'change from baseline to one year of appliance wear', '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'}, {'measure': 'change in overall score of CPQ SF8', 'timeFrame': 'change from baseline to one year of appliance wear', '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'}, {'measure': 'validation of CPQ 11-14 in Croatia', 'timeFrame': 'one year', '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'}, {'measure': 'validation of P CPQ in Croatia', 'timeFrame': 'one year', '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"}, {'measure': 'validation of FIS in Croatia', 'timeFrame': 'one year', '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"}]}, 'conditionsModule': {'keywords': ['quality of life'], 'conditions': ['Malocclusion, Angle Class II']}, 'referencesModule': {'references': [{'pmid': '31444594', 'type': 'RESULT', '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."}, {'pmid': '31118532', 'type': 'RESULT', '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.'}, {'type': '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.'}, {'type': '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.'}, {'type': 'RESULT', 'citation': 'Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.'}, {'pmid': '34402117', 'type': 'RESULT', '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."}, {'type': '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.'}, {'type': '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.'}, {'type': '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.'}, {'type': 'RESULT', 'citation': 'Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.'}, {'type': '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.'}, {'pmid': '41211711', 'type': 'DERIVED', 'citation': 'Hana CA, Martina Z, Sheela PT, Vedrana T, Martin PJ, Stjepan S. Mandibular Advancement in Dentofacial Orthopaedics: Effects on Pharyngeal Airway, Dentoskeletal Characteristics and Quality of Life: A Randomised Controlled Trial. Orthod Craniofac Res. 2025 Nov 10. doi: 10.1111/ocr.70056. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment.\n\nMethods: 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* distal molar occlusion, overjet \\>5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4\n\nExclusion Criteria:\n\n* mental retardation'}, 'identificationModule': {'nctId': 'NCT03455634', 'acronym': 'PONCOS', 'briefTitle': 'Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success', 'organization': {'class': 'OTHER', 'fullName': 'University of Rijeka'}, 'officialTitle': 'Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome', 'orgStudyIdInfo': {'id': '2170-24-01-15-2'}, 'secondaryIdInfos': [{'id': '2170-29-02/1-14-5', 'type': 'OTHER', 'domain': 'Clinical Hospital Center Rijeka, Croatia'}, {'id': '13.06.2.1.53', 'type': 'OTHER_GRANT', 'domain': 'University of Rijeka'}, {'id': 'uniri-biomed-18-22', 'type': 'OTHER_GRANT', 'domain': 'University of Rijeka'}, {'id': 'IP9', 'type': 'OTHER_GRANT', 'domain': 'J. J. Strossmayer University of Osijek, Faculy of Dental Medicine and Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Twin Block', 'description': 'Twin Block functional appliance', 'interventionNames': ['Device: Twin Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sander', 'description': 'Sander bite jumping appliance', 'interventionNames': ['Device: Sander bite jumping appliance']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no intervention'}], 'interventions': [{'name': 'Twin Block', 'type': 'DEVICE', 'description': 'functional appliances for the stimulation of the mandibular growth', 'armGroupLabels': ['Twin Block']}, {'name': 'Sander bite jumping appliance', 'type': 'DEVICE', 'description': 'functional appliances for the stimulation of the mandibular growth', 'armGroupLabels': ['Sander']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HR-51000', 'city': 'Rijeka', 'state': 'Primorsko-goranska County', 'country': 'Croatia', 'facility': 'University of Rijeka, Faculty of Dental Medicine', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}], 'overallOfficials': [{'name': 'Stjepan Spalj', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Rijeka Faculty of Dental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Visnja Katic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Hospital Center Rijeka', 'class': 'OTHER'}, {'name': 'University of Rijeka', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Post-doc', 'investigatorFullName': 'Visnja Katic', 'investigatorAffiliation': 'University of Rijeka'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-14', 'type': 'RELEASE'}, {'date': '2024-10-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Stjepan Spalj, Professor, University of Rijeka'}}}}