Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT05597956
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2022-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}], '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': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-10-20', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the color of opacities', 'timeFrame': 'Between five and six months', 'description': "Measured in color changes of opacities using the CIE L\\*A\\*B\\* system. The color of (coated) objects is visualized and quantified by using the CIELAB color space. The 3-dimensional color space is built-up from three axes that are perpendicular to one another.The L\\*-axis gives the lightness: a white object has an L\\* value of 100 and the L\\* value of a black object is 0. The so-called achromatic colors, the shades of grey, are on the L\\*-axis.\n\nChromatic ('real') colors are described by using the two axes in the horizontal plane. The a\\*-axis is the green-red axis and the b\\*-axis goes from blue (-b\\*) to yellow (+b\\*).its measurement is possible thanks to the spectrophotometer.\n\nClinical improvement and better visual perception of infiltrated enamel defects"}, {'measure': 'Change in the density of opacities', 'timeFrame': 'Between five and six months', 'description': 'DIAGNOdent is a diagnostic method based on an intermittent red fluorescence laser with a wavelength of 655 nm and 1 mW (milliwatt )that penetrates several millimeters from the tooth surface.'}], 'secondaryOutcomes': [{'measure': 'aesthetic change of opacities', 'timeFrame': 'Between five and six months', 'description': 'Satisfaction questionnaire. A post-treatment questionnaire will be passed with questions regarding the satisfaction of the patient and parents. The results will be classified from 0 to 4, with 0 being not at all satisfied and 4 being very satisfied.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children, Adult', 'Molar Incisor Hypomineralization', 'Dental Diseases', 'Opacity', 'Anterior Teeth']}, 'descriptionModule': {'briefSummary': 'Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. In hypomineralized enamel, light rays encounter multiple interfaces between organic and mineral fluids, with different refractive indices. At each interface, the light is deflected and reflected, producing an overexposed "optical labyrinth" that is perceived as a yellow, white, or brown stain.\n\nThe term "infiltration" has been modified and developed commercially in Germany for the treatment of non-cavitated caries on smooth and proximal surfaces, in which the porosities of the enamel lesion are infiltrated with a low-viscosity resin, thus creating a barrier of diffusion, without the need for any type of additional material on the tooth surface.\n\nAn added positive effect of infiltration with the queens is that the enamel lesions lose their whitish appearance when the microporosities are filled, mimicking the area of the lesion with the remaining healthy enamel. This effect is what has led clinicians to adapt this treatment for the management of enamel defects.\n\nGiven the growing interest in the treatment of opacities in the anterior sector, due to the demanding contemporary aesthetic requirements, and the increased acceptance of minimally invasive therapies, the need has been seen to seek greater predictability for the treatment of defects. of conservative enamel from an early age and offer effective therapeutic alternatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n. Pediatric patients, aged between 9 and 16 years.\n\n* Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors.\n* Patients who present at least one opacity in the central incisors.\n* Go to the dental clinic for revision or treatment of the University of Valencia.\n\nExclusion Criteria:\n\n* Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.'}, 'identificationModule': {'nctId': 'NCT05597956', 'briefTitle': 'Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients', 'orgStudyIdInfo': {'id': 'O00017836e2200003229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'white defects', 'description': 'Evaluate the infiltration of the defects.', 'interventionNames': ['Procedure: yellow defects', 'Procedure: brown defects']}, {'type': 'EXPERIMENTAL', 'label': 'yellow defects', 'description': 'Evaluate the infiltration of the defects.', 'interventionNames': ['Procedure: white defects', 'Procedure: brown defects']}, {'type': 'EXPERIMENTAL', 'label': 'Brown defects', 'description': 'Evaluate the infiltration of the defects.', 'interventionNames': ['Procedure: white defects', 'Procedure: yellow defects']}], 'interventions': [{'name': 'white defects', 'type': 'PROCEDURE', 'description': '"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".', 'armGroupLabels': ['Brown defects', 'yellow defects']}, {'name': 'yellow defects', 'type': 'PROCEDURE', 'description': '"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".', 'armGroupLabels': ['Brown defects', 'white defects']}, {'name': 'brown defects', 'type': 'PROCEDURE', 'description': '"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".', 'armGroupLabels': ['white defects', 'yellow defects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Universitat de València', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The project will be carried out by a research team. Where there will be a principal investigator, and a collaborator who will carry out the clinical experimentation part.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Montserrat Catalá Pizarro', 'investigatorAffiliation': 'University of Valencia'}}}}