Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-29 @ 6:56 AM
Study NCT ID:
NCT04458506
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Unilateral Posterior Cross Bite in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010155', 'term': 'Palatal Expansion Technique'}], 'ancestors': [{'id': 'D009971', 'term': 'Orthodontics, Corrective'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal expansion at the level of the palatal median suture - the change fram Baseline', 'timeFrame': 'At baseline, directly after expansion and one year after expansion', 'description': 'Skeletal expansion evaluated by computed tomography at three time points in both arms. The change in width of the palatal median suture is going to be evaluated and compared to the Baseline values, in both arms.'}, {'measure': 'The change of inclination of teeth and alveolar bone and side effects between the time points', 'timeFrame': 'At baseline, directly after expansion and one year after expansion', 'description': 'Dental effects and side effects evaluated by computed tomography at three time points in both arms.The change in degree of angulation and inclination of the dental structures (e.g. tooth inclinations) is going to be evaluated and compared to the Baseline values, in both arms.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the soft tissue changes', 'timeFrame': 'At baseline, directly after expansion, six months and one year after expansion', 'description': '3D assessment of the soft tissue changes during and after treatment by 3D -photography'}, {'measure': 'Evaluation of pain and discomfort', 'timeFrame': 'Three times during the first week after inserting the appliances', 'description': 'Questionnaire The Questionnaire has some questions with Visual Analogue Scale. With the minimum value of "0" and maximum value of "10". Higher values mean worse outcome.\n\nOther questions in the questionnaire have a "yes" and "No" nature.'}, {'measure': 'Evaluation of Temporomandibular Disorder (TMD)', 'timeFrame': 'Baseline and one year after expansion', 'description': 'Questionnaire The questionnaire has no scale and the questions have a "Yes" och "No" nature.'}, {'measure': 'Cost-effectiveness of two treatment modalities in treatment of posterior cross bite', 'timeFrame': 'Through study completion, an average of 18 months', 'description': 'Evaluation of both the direct and indirect costs of the treatment, number of emergency visits, treatment duration (in total) etc are going to be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion', 'Maxillary Expansion', 'Pain Children']}, 'referencesModule': {'references': [{'pmid': '14580028', 'type': 'BACKGROUND', 'citation': 'Petren S, Bondemark L, Soderfeldt B. A systematic review concerning early orthodontic treatment of unilateral posterior crossbite. Angle Orthod. 2003 Oct;73(5):588-96. doi: 10.1043/0003-3219(2003)0732.0.CO;2.'}, {'pmid': '36331513', 'type': 'DERIVED', 'citation': 'Hansson S, Josefsson E, Lindsten R, Magnuson A, Bazargani F. Pain and discomfort during the first week of maxillary expansion using two different expanders: patient-reported outcomes in a randomized controlled trial. Eur J Orthod. 2023 May 31;45(3):271-280. doi: 10.1093/ejo/cjac067.'}]}, 'descriptionModule': {'briefSummary': 'Rapid maxillary expansion and quad-helix are two well established appliances in dentistry used for posterior cross bite treatment. This study aims to compare this two different appliances in patients in their early mixed dentition, regarding treatment effects of the extra oral soft tissue but also dental and skeletal effects, if the children experience any pain and discomfort during treatment and the study also aims to make a cost minimization analysis. Comparison of these different treatments are barely made and no randomized controlled trial is yet published. No study has evaluated the difference of subjective experience during these two treatments. After this study we will know which one of these two appliances are the most effective, regarding cost minimization and treatment result but we are also able to put it in relation to the patients subjective experience'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children in the early mixed dentition\n* Unilateral posterior cross bite including the first permanent molar\n\nExclusion Criteria:\n\n* No ongoing sucking habits\n* Craniofacial syndroms\n* Earlier Orthodontic treatments\n* Not able to independently understand and answer the questionnaires'}, 'identificationModule': {'nctId': 'NCT04458506', 'briefTitle': 'Treatment of Unilateral Posterior Cross Bite in Children', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '260581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid Maxillary Expander (RME)', 'description': '36 patients will be treated with RME in order to correct their unilateral posterior cross bite', 'interventionNames': ['Procedure: Maxillary expansion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quad Helix (QH)', 'description': '36 patients will be treated with QH in order to correct their unilateral posterior cross bite', 'interventionNames': ['Procedure: Maxillary expansion']}], 'interventions': [{'name': 'Maxillary expansion', 'type': 'PROCEDURE', 'description': 'Correction of the unilateral posterior cross bite in children', 'armGroupLabels': ['Quad Helix (QH)', 'Rapid Maxillary Expander (RME)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-70111', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Postgraduate Dental Education Center', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Farhan Bazargani, DDS, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Örebro University, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Jönköping County', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}