Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-25 @ 6:30 AM
Study NCT ID:
NCT06692257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-18
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of orofacial function (NOT-S) - (score from 0 to 12)', 'timeFrame': 'Baseline', 'description': 'The following functions are addressed during the interview: (I) sensory function, (II) breathing, (III) habits, (IV) chewing and swallowing, (V) drooling and (VI) dryness of the mouth. The following functions are evaluated during the physical examination: (1) face at rest, (2) nose breathing, (3) facial expression, (4) masticatory muscle and jaw function, (5) oral motor function and (6) speech. For the evaluation of orofacial dysfunction during the clinical examination, the participants will be asked to perform tasks for each item in accordance with the illustrated manual. Each item has criteria for the respective function. A "YES" response or task the meets the criteria for compromised function will be scored 1 point, indicating dysfunction in the respective domain. A "NO" response or task that does not meet the criteria will be scored zero. The total is the sum of the points of all domains and ranges from 0 to 12, with higher scores denoting greater orofacial disfunction.'}], 'secondaryOutcomes': [{'measure': 'Assessment of hypersensitivity in teeth with MIH: Visual analog scale (VAS)', 'timeFrame': 'Baseline', 'description': 'The Wong-Baker Faces Pain Scale was initially developed for children to facilitate communication about pain. This scale uses a set of faces that ranges from a smiling expression (without pain) to a crying expression (worse pain possible), enabling children to indicate the intensity of their pain in a visually understandable way. The scale is used with children three years of age and older, facilitating communication and improving the assessment so that the management of the pain can be addressed.'}, {'measure': 'Schiff cold air sensitivity scale (SCASS)', 'timeFrame': 'Baseline', 'description': "The SCASS will be used to assess the child's response to the stimulus and will be scored as follows: 0 = no response to the stimulus; 1 = response to the stimulus, child considers stimulus painful; 2 = response to the stimulus, child moves away from stimulus; 3 = response to the stimulus, child moves away from the stimulus and asks for its immediate interruption."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Molar Hypomineralization, Incisor']}, 'referencesModule': {'references': [{'pmid': '40467310', 'type': 'DERIVED', 'citation': 'Pernomiam FC, Mandetta ARH, Ribeiro CDPV, Camargo CCB, Romano IMF, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Duran CCG, Motta LJ, Bussadori SK. Orofacial functions with emphasis on breathing and chewing patterns in individuals with and without molar incisor hypomineralisation: observational study protocol conducted in a dental clinic in Brazil. BMJ Open. 2025 Jun 4;15(6):e101725. doi: 10.1136/bmjopen-2025-101725.'}]}, 'descriptionModule': {'briefSummary': 'Molar incisor hypomineralization (MIH) is a qualitative developmental defect of the enamel with a complex, multifactorial nature and a significant genetic component that predominantly affects the permanent first molars and, occasionally, the permanent incisors. Individuals with MIH have a compromised stomatognathic system manifested by muscle hyperactivity under postural and dynamic conditions. However, there is a gap in knowledge on the specific functional abnormalities that these individuals experience. Early identification and intervention, with a focus on the prevention of orofacial dysfunctions and deviations in facial growth and development, are aspects of the utmost importance. Therefore, the aim of the proposed study is to perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH. Methods and Analysis: Assessments will be performed using the Nordic Orofacial Test - Screening (NOT-S). Descriptive statistics will be performed and comparisons will be made using the chi-square test, adopting a 5% significance level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted with children 6 to 12 years of age enrolled at the pediatric dentistry clinic of Nove de Julho University. The participants will be assessed in a single session during a visit to the clinic. All assessments will be performed by the same researcher.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 6 to 12 years of age with a complete mixed dentition with all first molars present and in occlusion;\n* Having all first molars erupted, without caries or previous treatment;\n* Inclusion criteria for the MIH group: at least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria).\n\nExclusion Criteria:\n\n* Children with amelogenesis and dentinogenesis imperfecta;\n* Children undergoing orthodontic treatment;\n* Children with a genetic syndrome;\n* Children with the premature loss of deciduous teeth;\n* Children with acute respiratory problems;\n* Children in treatment.'}, 'identificationModule': {'nctId': 'NCT06692257', 'briefTitle': 'Orofacial Functions in Individuals With and Without Molar Incisor Hypomineralization', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Orofacial Functions With Emphasis on Breathing and Chewing Patterns in Individuals With and Without Molar Incisor Hypomineralization: Observational Study Protocol', 'orgStudyIdInfo': {'id': 'Orofacial functions'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals without MIH', 'description': 'All permanent molars without indices compatible with MIH', 'interventionNames': ['Behavioral: Observation']}, {'label': 'Individuals with MIH', 'description': 'At least one permanent molar with indices compatible with MIH (code 2, 21, 22 and 3 - Ghanim criteria)', 'interventionNames': ['Behavioral: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'BEHAVIORAL', 'description': 'To perform a comparative analysis of orofacial functions with an emphasis on breathing and chewing patterns in individuals with and without MIH.', 'armGroupLabels': ['Individuals with MIH', 'Individuals without MIH']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sandra Kalil Bussadori', 'investigatorAffiliation': 'University of Nove de Julho'}}}}