Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-11 @ 5:02 AM
Study NCT ID:
NCT03160950
Status:
UNKNOWN
Last Update Posted:
2018-07-16
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Crowns Fabricated Using LuxaCrown
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of anatomical form', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Anatomical form will be assessed and scored according to Dijken modification of USPHS criteria.'}, {'measure': 'Change of marginal adaptation', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Marginal adaptation will be assessed and scored according to Dijken modification of USPHS criteria.'}, {'measure': 'Change of color match', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Color match will be assessed and scored according to Dijken modification of USPHS criteria.'}, {'measure': 'Change of marginal discoloration', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Marginal discoloration will be assessed and scored according to Dijken modification of USPHS criteria.'}, {'measure': 'Change of surface roughness', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Surface roughness will be assessed and scored according to Dijken modification of USPHS criteria.'}, {'measure': 'Change of secondary caries', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Secondary caries will be assessed and scored according to Dijken modification of USPHS criteria.'}, {'measure': 'Change of wear', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'The severity of attrition will be scored as described by Pergamalian'}, {'measure': 'Change of pulpal compatibility', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Assessment of the pulpal response by the FDI criteria'}, {'measure': 'Change of plaque index', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Plaque index will be assessed and scored according to Sillness and Loe, 1964'}, {'measure': 'Change of modified papillary bleeding index', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Measurement and scoring of modified papillary bleeding index (Barnett et al.)'}], 'secondaryOutcomes': [{'measure': 'Change of patient satisfaction', 'timeFrame': '1 week, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months', 'description': 'Patient satisfaction will be assessed by FDI criteria.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['LuxaCrown', 'Single Crown Restoration']}, 'descriptionModule': {'briefSummary': 'A single arm non-blinded study is planned to evaluate the durability of the crowns fabricated using a novel composite based material, LuxaCrown (DMG, Germany). The durability of these crowns will be assessed for anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, secondary caries, pulpal compatibility, plaque index and modified papillary bleeding index with intensive follow up for 2 years (at 1 week, 3rd, 6th, 12th, 18th and 24th month), and then a yearly follow-up for additional 3 years (at 36th, 48th and 60th month).\n\nA total of 50 patients will be selected and one tooth per subject will be included. For the purpose of study only the healthy adult patients with age range of 25 - 60 years who would be requiring Single crown restoration in the permanent anterior / posterior teeth, either due to caries, pulpal involvement or trauma, will be selected. Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. For broken teeth, only the teeth with \\> 1/2 crown structure remaining or in case of teeth with \\<1/2 crown structure fractured that can be restored with conventional post and core will be selected. In general, patients with bruxism, or with severe periodontal disease, mobility grade 2 or 3 shall be excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult patients with age range 25 - 60 years\n* Only the patients who would be requiring Single crown restoration in the permanent anterior / posterior teeth will be selected for the purpose of study. Single crowns are usually indicated in either of the following conditions\n\n * Extensive coronal / structural broken tooth due to caries or trauma\n * Teeth undergone successful endodontic therapy (no signs of failure- asymptomatic, no tenderness on percussion, healthy associated soft tissue)\n * Microdonts\n\nTeeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. The success of the endodontic therapy shall be evaluated using the standardized clinical and radiographic criteria by the endodontist.\n\n* Broken teeth with \\> ½ crown structure remaining will be selected.\n* Broken teeth with \\< ½ crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core.\n* Patients with good Occlusal Contact will be selected.\n* Patients who would be giving the Signed Informed Consent shall only be enrolled for the study.\n* Only the teeth showing mobility grade 0 and 1 as per Miller's Criteria shall be selected for the purpose of study.\n\nExclusion Criteria:\n\n* Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit.\n* Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study.\n* Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement.\n* If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Miller's criteria, it shall be excluded from the study.\n* History of any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded.\n* Teeth with fracture of crown en-masse (Ellis Class VIII) fracture or which are badly mutilated such that a very minimal or No coronal structure is remaining will be excluded.\n* Hypoplastic / malformed teeth will not be selected for the purpose of study."}, 'identificationModule': {'nctId': 'NCT03160950', 'briefTitle': 'Clinical Efficacy of Crowns Fabricated Using LuxaCrown', 'organization': {'class': 'INDUSTRY', 'fullName': 'DMG Dental Material Gesellschaft mbH'}, 'officialTitle': 'Evaluating the Longevity and Safety of Full-coverage Crowns Fabricated With LuxaCrown Over a Period of 5 Years in 25-60 Year Old Indian Population: An Uncontrolled Trial', 'orgStudyIdInfo': {'id': 'DEPEND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LuxaCrown', 'interventionNames': ['Device: LuxaCrown']}], 'interventions': [{'name': 'LuxaCrown', 'type': 'DEVICE', 'description': "Teeth that would be requiring RCT, would be initially treated by a endodontist using the standardized principles of rotary endodontics.\n\nRestoration using the LuxaCrown as a direct composite crown: In short, the impression material will be loaded with the LuxaCrown material (DMG, Germany). Approx. 0:40 minutes after the start of mixing, the filled impression will be placed in the patient's mouth and will stay there for approx. 1:45 - 2:20 minutes, that is, till the material is partially set. The impression will then be taken out and the material will be allowed to set outside patient's mouth up to approximately 5 minutes after the start of mixing. The Crown will then be finished using a fine buff and pumice, followed by application of Glaze and Bond (DMG, Germany). The preparation will then be cleaned and slightly roughened with a bur or sand blaster at the adhesion sites. The crown fabricated will then be cemented using PermaCem 2.0 luting cement (DMG, Germany).", 'armGroupLabels': ['LuxaCrown']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135001', 'city': 'Yamuna Nagar', 'state': 'Haryana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Inder Kumar Pandit, Dr.', 'role': 'CONTACT', 'email': 'drpandit3080@gmail.com', 'phone': '+91 173220804', 'phoneExt': '46'}, {'name': 'Neeraj Gugnani, Dr.', 'role': 'CONTACT', 'email': 'drgugnani@gmail.com', 'phone': '+91 173220804', 'phoneExt': '46'}, {'name': 'Neeraj Gugnani, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vijay Singh, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Viram Upadhaya, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shalini Gugnani, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sugandhi Soni, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Monika Gupta, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'DAV (C) Dental College Model Town', 'geoPoint': {'lat': 30.12796, 'lon': 77.28371}}], 'centralContacts': [{'name': 'Marcus Cebula, Dr.', 'role': 'CONTACT', 'email': 'mcebula@dmg-dental.com', 'phone': '00494084006', 'phoneExt': '232'}, {'name': 'Susanne Effenberger, Dr.', 'role': 'CONTACT', 'email': 'seffenberger@dmg-dental.com', 'phone': '00494084006', 'phoneExt': '185'}], 'overallOfficials': [{'name': 'Neeraj Gugnani, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pedodontics and Preventive Dentistry, DAV Dental College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DMG Dental Material Gesellschaft mbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}