Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 8:50 AM
Study NCT ID:
NCT05945758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esthetic and Clinical Assessment of Injectable Resin Composite Technique
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': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Esthetic anatomical form at 6,12,18& 24 months.', 'timeFrame': 'T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.', 'description': 'FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Color match and translucency at 6,12,18& 24 months.', 'timeFrame': 'T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.', 'description': 'FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).'}, {'measure': 'Change from baseline in Surface and marginal staining at 6,12,18& 24 months.', 'timeFrame': 'T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.', 'description': 'FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).'}, {'measure': 'Change from baseline in Surface lustrous at 6,12,18& 24 months.', 'timeFrame': 'T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.', 'description': 'FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['injectable resin composite', 'conventional layering technique', 'FDI', 'multiple spacing'], 'conditions': ['Clinical Performance']}, 'descriptionModule': {'briefSummary': 'injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not.', 'detailedDescription': 'The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The injection molding technique has the advantage of replicating the excellent anatomy defined by a lab-made diagnostic wax-up whereby it would be used for the fabrication of direct restorations, so excellent anatomy results, verifies aesthetics, phonetics, and occlusion, avoids misunderstandings, as it is easy to implement and repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sound and vital upper anterior teeth.\n* Spacing in the maxillary anterior teeth area ranging from .5mm to 2mm.\n* Minor misalignment, correction of peg laterals.\n\nExclusion Criteria:\n\n* Non-vital, fractured, or cracked teeth.\n* Teeth with caries or in need of replacement of existing restorations.\n* Rampant caries, atypical extrinsic staining of teeth.\n* Heavy occlusion and occlusal contacts or history of bruxism.\n* Severe periodontal affection.'}, 'identificationModule': {'nctId': 'NCT05945758', 'briefTitle': 'Esthetic and Clinical Assessment of Injectable Resin Composite Technique', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Esthetic and Clinical Assessment of Injectable Resin Composite Technique Compared to Conventional Layering Technique in Patients With Multiple Spacing in the Maxillary Anterior Teeth Area.', 'orgStudyIdInfo': {'id': 'Injection Molding Technique'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spacing in the maxillary anterior teeth area treated with injectable resin composite technique.', 'description': 'The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation.\n\nThe Spaces will be restored with injectable resin composite.', 'interventionNames': ['Procedure: Injectable resin composite technique.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spacing in the maxillary anterior teeth area treated with conventional layering composite technique.', 'description': 'shade mapping of enamel and dentin, then isolation the teeth with rubber dam. Palatal index will be done on waxing up and applied against the palatal surface to check the adaptation of the index. Then, the enamel shade adapted on the index in the spacing area. index will be placed back on the anterior teeth to build the palatal wall. A brush will be used to adapt the composite to the margin. After removing excess material, light curing will be carried out for 20 seconds. The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready.', 'interventionNames': ['Procedure: Conventional layering technique']}], 'interventions': [{'name': 'Injectable resin composite technique.', 'type': 'PROCEDURE', 'otherNames': ['Beautiful Flow Plus F03, Medium Viscosity, Shofu Dental'], 'description': 'A metal impression tray was filled with transparent vinyl polysiloxane (EXACLEAR, GC) and used to copy the stone model with the wax-up. Then, the replica will be separated from metal tray and a needle-shaped bur will be used to drill holes through the silicone key ending in the middle of the incisal edge. It will be checked whether the holes were large enough to enable the tip of the composite syringe to pass easily and completely. Neighbouring teeth (mesial and distal one) isolated using Teflon tape, as each tooth will individually be restored for establishment of satisfactory contact points. Following etching and rinsing, the tooth dried, and a dental cord (Ultrampak, Ultradent) will be packed into sulcus for mechanical prevention of subgingival composite flow. Then, the transparent silicone index will be placed in the correct intraoral position, and a syringe filled with flowable composite will be inserted through the hole on the incisal edge.', 'armGroupLabels': ['Spacing in the maxillary anterior teeth area treated with injectable resin composite technique.']}, {'name': 'Conventional layering technique', 'type': 'PROCEDURE', 'otherNames': ['Enamel and Dentin shades'], 'description': 'the palatal surface will be restored by enamel shade; adapted on the index in the spacing area then The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready.', 'armGroupLabels': ['Spacing in the maxillary anterior teeth area treated with conventional layering composite technique.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Tasneem Mokhtar Ali Morad', 'investigatorAffiliation': 'Cairo University'}}}}