Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT03513003
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2018-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of a Pacifier to Correct Malocclusions in Young 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2018-04-27', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posterior cross bite', 'timeFrame': '1 year', 'description': 'presence of posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite.'}, {'measure': 'Anterior open bite', 'timeFrame': '1 year', 'description': 'presence of anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.'}], 'secondaryOutcomes': [{'measure': 'Facial movement', 'timeFrame': '1 year', 'description': 'Lip contraction during swallowing of a sip of water'}, {'measure': 'Lip competence', 'timeFrame': '1 year', 'description': 'Contact between the upper and the lower lips at rest'}, {'measure': 'Facial morphology', 'timeFrame': '1 year', 'description': '3D measurements of facial proportions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion']}, 'referencesModule': {'references': [{'pmid': '20496855', 'type': 'BACKGROUND', 'citation': 'Dimberg L, Bondemark L, Soderfeldt B, Lennartsson B. Prevalence of malocclusion traits and sucking habits among 3-year-old children. Swed Dent J. 2010;34(1):35-42.'}, {'pmid': '16532883', 'type': 'BACKGROUND', 'citation': 'Warren JJ, Slayton RL, Bishara SE, Levy SM, Yonezu T, Kanellis MJ. Effects of nonnutritive sucking habits on occlusal characteristics in the mixed dentition. Pediatr Dent. 2005 Nov-Dec;27(6):445-50.'}, {'pmid': '25000602', 'type': 'BACKGROUND', 'citation': 'Sousa RV, Pinto-Monteiro AK, Martins CC, Granville-Garcia AF, Paiva SM. Malocclusion and socioeconomic indicators in primary dentition. Braz Oral Res. 2014;28:54-60. doi: 10.1590/s1806-83242013005000032.'}, {'pmid': '26399737', 'type': 'BACKGROUND', 'citation': 'Filippi C, Filippi A, Verna C. [Orthodontic therapy in the early childhood using pacifier?]. Swiss Dent J. 2015;125(9):959-70. doi: 10.61872/sdj-2015-09-03. French, German.'}, {'pmid': '29532184', 'type': 'BACKGROUND', 'citation': 'Schmid KM, Kugler R, Nalabothu P, Bosch C, Verna C. The effect of pacifier sucking on orofacial structures: a systematic literature review. Prog Orthod. 2018 Mar 13;19(1):8. doi: 10.1186/s40510-018-0206-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of a pacifier (102 Medical Pacifier, Curaprox, Switzerland) on malocclusions like posterior crossbite, anterior open bite, larger overjet and tongue dysfunction in young children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who are sucking the pacifier and / or baby bottle for the last 6 months in use.\n* Manifesting posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite.\n\nAND / OR\n\n\\- Manifesting anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.\n\nExclusion Criteria:\n\n* Children who are thumb- or fingersucking (or sucking other objects)\n* syndromic or cleft patients\n* patients with history of cranio-facial trauma, history of temporomandibular joint infection or musculo-skeletal asymmetry (e.g. scoliosis, torticollis)\n* patients with systematic diseases\n* patients currently under or after orthodontic Treatment\n* patients with ankylosed teeth (e.g. after dental trauma).'}, 'identificationModule': {'nctId': 'NCT03513003', 'briefTitle': 'The Use of a Pacifier to Correct Malocclusions in Young Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'The Use of a Pacifier to Correct Malocclusions in Young Children', 'orgStudyIdInfo': {'id': 'UZB-Pacifier'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional pacifier', 'description': 'Swap from the habitual pacifier to a functional pacifier', 'interventionNames': ['Device: Functional Pacifier']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stop habit', 'description': 'Stop the use of the habitual pacifier and or baby bottle', 'interventionNames': ['Behavioral: Stop habit']}], 'interventions': [{'name': 'Functional Pacifier', 'type': 'DEVICE', 'description': 'Children swap from their habitual pacifier to the functional pacifier and stop baby bottle', 'armGroupLabels': ['Functional pacifier']}, {'name': 'Stop habit', 'type': 'BEHAVIORAL', 'description': 'Children stop the use of their pacifier and/or baby bottle', 'armGroupLabels': ['Stop habit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4058', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Carlalberta Verna, DDS, PhD, Professor and Chair', 'role': 'CONTACT', 'email': 'carlalberta.verna@unibas.ch', 'phone': '+41 61 267 26 40'}], 'facility': 'UZB, University Center for Dental Medicine', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Carlalberta Verna, DDS, PhD', 'role': 'CONTACT', 'email': 'carlalberta.verna@unibas.ch', 'phone': '0041 061 2672641'}], 'overallOfficials': [{'name': 'Carlalberta Verna, DDS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Center for Dental Medicine, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}