Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-04-08 @ 3:12 PM
Study NCT ID:
NCT07234266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance and periodontal paremetres', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The clinical evaluation of restorations bonded to teeth will be performed using World Dental Federation (FDI) criteria in addition to periodontal parameters. Regarding FDI criteria, each property is typically scored on a 1 to 5 scale: 1- Clinically excellent, 2- Clinically good, 3- Clinically sufficient, 4- Clinically insufficient, 5- Clinically poor Regarding gingival index, 0-1: Clinically acceptable, 1-2: Clinically unacceptable Regarding plaque index, 0-1 clinically acceptable, 2 borderline, 3 clinically unacceptable In terms of probing pocket depth, ≤3 mm clinically acceptable, 4-5 mm borderline ≥6 mm s clinically unacceptable'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deep margin elevation', 'indirect restoration', 'additively manufactured', 'composite resin'], 'conditions': ['Deep Marginal Elevation']}, 'descriptionModule': {'briefSummary': 'In dentistry, particularly in posterior teeth with extensive caries or old restorations, the extension of restoration margins below the gingival level presents a significant clinical challenge. In such cases, restorative procedures become more complicated, periodontal health may be adversely affected, and long-term tissue loss can occur. To overcome this problem, the "Deep Margin Elevation" technique has been developed. This approach aims to raise subgingival margins caused by caries or fractures above the gingival level, thereby providing a healthier and more favorable foundation for successful treatment.\n\nIn this study, two different materials will be used for deep margin elevation, followed by restoration of the teeth with indirect restorations fabricated using additive manufacturing technology, which has become increasingly popular in recent years. Two different additive manufacturing resins will also be applied in the restorative phase. The teeth treated with deep margin elevation and indirect restorations will be evaluated at baseline, 6 months, and 12 months according to the FDI criteria, as well as periodontal parameters due to the involvement of the gingival region.\n\nThis study aims to highlight the importance of material selection in restorative treatment planning and to scientifically demonstrate the impact of the applied technique on surrounding tissues. Furthermore, it will provide an evidence-based perspective on how adopting a tissue-friendly approach during restorative procedures may contribute to favorable long-term outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who apply to Mersin University Faculty of Dentistry between 01.12.2025 and 01.03.2026 for restorative treatment of their teeth\n* Patients aged between 18 and 84 years\n* Patients without parafunctional habits (such as bruxism, clenching, or foreign object chewing)\n* Vital or non-vital molar and premolar teeth with a clinical indication for inlay/onlay restoration\n* Teeth with deep cavities and margins located at or slightly below the gingival level\n* Defects limited to the occlusal surface and one proximal surface\n* Occlusal defects extending beyond one-third of the distance between fissure and cusp tip, including at least one cusp\n* Posterior teeth with an indication for deep margin elevation without violation of the biologic width\n* Teeth with opposing natural teeth or fixed prosthetic restorations\n* Teeth with the presence of adjacent proximal contacts\n\nExclusion Criteria:\n\n* Teeth with fractures or cracks\n* Patients with temporomandibular joint disorders\n* Patients with malocclusion, bruxism, or parafunctional habits\n* Posterior teeth without opposing natural teeth or fixed prosthetic restorations\n* Posterior teeth without adjacent proximal contacts\n* Patients with a history of allergy to the components of the restorative materials used\n* Patients with severe gingival enlargement, gingival recession, or active periodontal disease\n* Teeth requiring deep margin elevation that present with non-physiological mobility, fistula, or periapical lesions'}, 'identificationModule': {'nctId': 'NCT07234266', 'briefTitle': 'The Effect of Material Choice on Clinical Outcomes in Deep Margin Elevation', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Effect of Restorative Material Selection on Periodontal and Clinical Success in Teeth Restored With Indirect Restorations Fabricated by Additive Manufacturing After Deep Margin Elevation: A One-Year Clinical Follow-Up Study', 'orgStudyIdInfo': {'id': '2025/909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Saremco print resin- 3M Filtek One Bulk Fill Restorative', 'description': 'The teeth is restored with Saremco print resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative.', 'interventionNames': ['Device: 3d printed resin restoration with deep margin elevation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saremco print resin- GC Gaeanial Universal Injectable', 'description': 'The teeth is restored with Saremco print resin after deep margin elevation is performed with GC Gaeanial Universal Injectable', 'interventionNames': ['Device: 3d printed resin restoration with deep margin elevation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Varseosmile TriniQ resin- 3M Filtek One Bulk Fill Restorative', 'description': 'The teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with 3M Filtek One Bulk Fill Restorative', 'interventionNames': ['Device: 3d printed resin restoration with deep margin elevation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Varseosmile TriniQ resin- GC Gaeanial Universal Injectable', 'description': 'The teeth is restored with Varseosmile TriniQ resin after deep margin elevation is performed with GC Gaeanial Universal Injectable', 'interventionNames': ['Device: 3d printed resin restoration with deep margin elevation']}], 'interventions': [{'name': '3d printed resin restoration with deep margin elevation', 'type': 'DEVICE', 'description': 'The teeth are restored with 3D printed permanent resins after deep margin elevation', 'armGroupLabels': ['Saremco print resin- 3M Filtek One Bulk Fill Restorative', 'Saremco print resin- GC Gaeanial Universal Injectable', 'Varseosmile TriniQ resin- 3M Filtek One Bulk Fill Restorative', 'Varseosmile TriniQ resin- GC Gaeanial Universal Injectable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33343', 'city': 'Mersin', 'state': 'Mersin', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra Cengiz Yanardag, DDS, PhD', 'role': 'CONTACT', 'email': 'esracengiz@mersin.edu.tr', 'phone': '0905052443472'}, {'name': 'Funda Sezer, DDS', 'role': 'CONTACT', 'email': 'szrrfunda@gmail.com', 'phone': '0905382140978'}, {'name': 'Esra Cengiz Yanardag, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Funda Sezer, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mersin University, Faculty of Dentistry', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'Esra Cengiz Yanardag, DDS, PhD', 'role': 'CONTACT', 'email': 'esracengiz@mersin.edu.tr', 'phone': '+905052443472'}, {'name': 'Funda Sezer, DDs', 'role': 'CONTACT', 'email': 'szrrfunda@gmail.com', 'phone': '0905382140978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Esra Cengiz Yanardag', 'investigatorAffiliation': 'Mersin University'}}}}