Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT07144605
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2025-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In our study, treatment was planned for moderately affected teeth according to the MIH Severity Index. The study was designed as a prospective, randomized, split-mouth trial. Group randomization was performed using the sealed envelope technique. In the same patient, VOCO GrandioBloc (VOCO GmbH, Cuxhaven, Germany) was applied to one tooth, while a GC Initial lithium disilicate block was applied to the symmetrical contralateral tooth.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the clinical status of the restorations', 'timeFrame': 'up to 6 months after intervention', 'description': 'The restorations were clinically evaluated in the oral cavity using the USPHS index.'}, {'measure': 'the status of the periapical tissues', 'timeFrame': 'Up to the 6th months', 'description': 'The periapical tissue status was assessed according to the Periapical Index (PAI).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAD-CAM, Indirect restorations', 'Molar Incisor Hypomineralization', 'MIH'], 'conditions': ['Molar Hypomineralization, Incisor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/s10266-023-00841-w', 'label': 'https://link.springer.com/article/10.1007/s10266-023-00841-w'}]}, 'descriptionModule': {'briefSummary': 'This study is about the long-term survival success of different, externally prepared fillings (Indirect restoration, CAD-CAM blocks) used in teeth with reduced mineral structure, namely Molar Incisor Hypomineralization (MIH), which is called chalk teeth in children.', 'detailedDescription': 'The aim of this study was to comparatively evaluate the long-term survival times and clinical success of nano-ceramic hybrid CAD-CAM blocks, Grandio Blocs (R) (VOCO), and glass-ceramic blocks, GC INITIAL LiSi (GC AMERICA INC. USA), according to USPHS criteria, after pulpal treatment in mandibular teeth with bilateral moderate molar incisor hypomineralization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:8-15 years old\n\n* Systemically healthy\n* Cooperative (Frankl 3-4)\n* Diagnosed with MIH for at least one permanent tooth\n* Symmetrical mandibular molars that fit the middle MIH classification (teeth with a tooth score of 7-9 in MIHSI)\n* Teeth without indication for root canal treatment\n* Teeth without percussion, abscess and fistula formation\n* Without periapical lesions\n* With post-eruption enamel fractures in the relevant teeth\n* Without mobility and pathological gingival pockets\n* Patients who agreed to participate in the study.\n\nExclusion Criteria:Teeth that are suitable for mild and severe classification\n\n* Non-cooperative (Frankl 1 and Frankl 2)\n* Teeth with extraction indication\n* Teeth that require root canal treatment\n* Teeth with periapical lesions, abscesses and fistula formation\n* Patients with mobility and pathological gingival pockets'}, 'identificationModule': {'nctId': 'NCT07144605', 'briefTitle': 'Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study', 'organization': {'class': 'OTHER', 'fullName': 'Necmettin Erbakan University'}, 'officialTitle': 'Comparison of the Long-Term Success of Different CAD-CAM Blocks Used as Indirect Restorations in Molar Incisor Hypomineralized Teeth: A Split Mouth Study', 'orgStudyIdInfo': {'id': 'NecmettinEU05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voco Grandio blocs(Grandio Blocs (R) VOCO)', 'description': 'Nanohybrid ceramic blocks, indirect restorative materials', 'interventionNames': ['Other: CAD-CAM, indirect restorations']}, {'type': 'EXPERIMENTAL', 'label': 'GC INITIAL LiSi Blocs (GC AMERICA INC. USA)', 'description': 'Glass ceramic blocks, indirect restorative materials', 'interventionNames': ['Other: CAD-CAM, indirect restorations']}], 'interventions': [{'name': 'CAD-CAM, indirect restorations', 'type': 'OTHER', 'description': 'Indirect restorations that we think will last longer than traditional filling materials in teeth with molar hypomineralization.', 'armGroupLabels': ['GC INITIAL LiSi Blocs (GC AMERICA INC. USA)', 'Voco Grandio blocs(Grandio Blocs (R) VOCO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42090', 'city': 'Konya', 'state': 'Meram', 'country': 'Turkey (Türkiye)', 'facility': 'Necmettin Erbakan University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "The participants don't want to share the individual information about study."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Necmettin Erbakan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Halenur Altan', 'investigatorAffiliation': 'Necmettin Erbakan University'}}}}