Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 8:32 PM
Study NCT ID:
NCT02631161
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2015-12-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of restorations with a re-intervention per all restorations', 'timeFrame': '36 months', 'description': 'Number of all restorations with a re-intervention being required per all placed restorations (events/sample)'}], 'secondaryOutcomes': [{'measure': 'Restoration score', 'timeFrame': '36 months', 'description': 'score according to FDI criteria'}, {'measure': 'Costs for initial and retreatment', 'timeFrame': 'recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)', 'description': 'Costs incurred for staff and material for initial and re-treatments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Cervical Non-carious Lesion']}, 'referencesModule': {'references': [{'pmid': '34817964', 'type': 'DERIVED', 'citation': 'Gostemeyer G, Seifert T, Jeggle-Engbert LM, Paris S, Schwendicke F. Glass Hybrid Versus Nanocomposite for Restoration of Sclerotic Non-carious Cervical Lesions: 18-Month Results of a Randomized Controlled Trial. J Adhes Dent. 2021 Dec 3;23(6):487-496. doi: 10.3290/j.jad.b2287831.'}, {'pmid': '33979577', 'type': 'DERIVED', 'citation': 'Schwendicke F, Muller A, Seifert T, Jeggle-Engbert LM, Paris S, Gostemeyer G. Glass hybrid versus composite for non-carious cervical lesions: Survival, restoration quality and costs in randomized controlled trial after 3 years. J Dent. 2021 Jul;110:103689. doi: 10.1016/j.jdent.2021.103689. Epub 2021 May 9.'}]}, 'descriptionModule': {'briefSummary': 'A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious cervical lesions.', 'detailedDescription': 'This is a prospective, randomized, monocenter parallel group study on restoration of tooth with non-carious cervical restorations. Each patient receives cervical restoration(s) either with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one experienced operator. One of two independent examiners will evaluate the restorations at baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria. Reliability of examination will be assessed on a random sample of 30 restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication of a restorative treatment for a sclerotic non-carious cervical lesion\n* lesions should be accessible for treatment and visual-tactile re-evaluation\n* sufficient moisture control should be possible\n* cervical margins should be located in dentin whereas the coronal margin should be located in enamel\n\nExclusion Criteria:\n\n* allergy/hypersensitivity against any of the used materials\n* participants should not be systematically ill, disabled, pregnant or participating in another study'}, 'identificationModule': {'nctId': 'NCT02631161', 'briefTitle': 'Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Randomized Controlled Trial on Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions', 'orgStudyIdInfo': {'id': 'GHyComp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EQUIA forte', 'description': 'Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte).', 'interventionNames': ['Other: Equia Forte']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek Supreme XT/Clearfil SE Bond', 'description': 'Dental non-carious cervical restorations are being restored with a composite resin based material/Adhesive combination (Medical product: Filtek Supreme XT/Clearfil SE Bond).', 'interventionNames': ['Other: Filtek Supreme XT/Clearfil SE Bond']}], 'interventions': [{'name': 'Equia Forte', 'type': 'OTHER', 'description': 'Restoration of cavities with a Glasshybrid material (Equia Forte)', 'armGroupLabels': ['EQUIA forte']}, {'name': 'Filtek Supreme XT/Clearfil SE Bond', 'type': 'OTHER', 'description': 'Restoration of cavities with a composite resin based material after placing an adhesive', 'armGroupLabels': ['Filtek Supreme XT/Clearfil SE Bond']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14197', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Sebastian Paris, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'GC Europe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr.', 'investigatorFullName': 'Falk Schwendicke', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}