Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 6:14 AM
Study NCT ID:
NCT07212660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-mouth design: each patient receives 2 dental fillings (test and control treatment in the same patient)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '4-10 days after placement of the dental fillings', 'description': 'The assessment of postoperative pain will be done by using the Wong-Baker Faces Pain rating Scale and includes questions about type and duration of pain, intensity of pain and the type of stimulus causing the pain. Values of 0 and 2 in the Wong-Baker Faces Pain Rating Scale are considered as no pain and values \\>2 as pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Insufficient Dental Filling']}, 'descriptionModule': {'briefSummary': 'The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.', 'detailedDescription': 'Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists.\n\nThe planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent of a legal representative (usually parents)\n* 2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss)\n* Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5)\n* Sufficient language skills of legal representative and children\n* Teeth in the need of indirect pulp capping if necessary (Operator decision)\n\nExclusion Criteria:\n\n* Cognitive impairment not age-appropriate\n* Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity)\n* Teeth with severely resorbed roots (anormal tooth mobility)\n* Direct pulp capping\n* Pulpotomy of an adjacent tooth in the same appointment\n* Noncompliant child\n* Allergies to material or anaesthetics used in the study\n* Sufficient isolation not possible'}, 'identificationModule': {'nctId': 'NCT07212660', 'briefTitle': 'A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivoclar Vivadent AG'}, 'officialTitle': 'A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth', 'orgStudyIdInfo': {'id': 'OTCS 369512033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fast curing mode', 'description': 'Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).', 'interventionNames': ['Device: Fast curing mode']}, {'type': 'OTHER', 'label': 'Conventional curing mode', 'description': 'Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).', 'interventionNames': ['Device: Conventional curing mode']}], 'interventions': [{'name': 'Fast curing mode', 'type': 'DEVICE', 'description': 'Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).', 'armGroupLabels': ['Fast curing mode']}, {'name': 'Conventional curing mode', 'type': 'DEVICE', 'description': 'Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).', 'armGroupLabels': ['Conventional curing mode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3360', 'city': 'Herzogenbuchsee', 'state': 'Canton of Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Klaus Neuhaus, Prof. Dr. med. dent.', 'role': 'CONTACT', 'email': 'klaus.neuhaus@unibe.ch', 'phone': '044 62 961 99 90'}], 'facility': 'N|DENT Zahnarztpraxis', 'geoPoint': {'lat': 47.18795, 'lon': 7.7062}}, {'zip': '6130', 'city': 'Willisau', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'contacts': [{'name': 'Eirini Stratigaki, Dr. med. dent.', 'role': 'CONTACT', 'email': 'estratigaki@icloud.com', 'phone': '044 41 970 37 55'}], 'facility': 'Zahnarztpraxis Chrüzhof', 'geoPoint': {'lat': 47.12183, 'lon': 7.99418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivoclar Vivadent AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}