Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-31 @ 7:14 AM
Study NCT ID:
NCT05466305
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2022-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013282', 'term': 'Stomatitis, Denture'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-15', 'size': 412064, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-18T13:44', 'hasProtocol': True}, {'date': '2022-07-15', 'size': 396131, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-19T14:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-07-08', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunological assessment using Salivary IgA level through ELISA test', 'timeFrame': '45 days', 'description': 'Immunological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy'}], 'secondaryOutcomes': [{'measure': 'Microbiological assessment using Staphylococcus Aureus, Staphylococcus Epidermis and Candida Albicans Colonization', 'timeFrame': '45 days', 'description': 'Microbiological assessment of maxillary complete denture reinforced by gold plated Cr-Co alloy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gold', 'Chrome', 'Denture', 'Mucosa'], 'conditions': ['Denture Stomatitis']}, 'descriptionModule': {'briefSummary': 'Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.', 'detailedDescription': 'Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.\n\nUsing metal alloys (gold alloys included) to make the framework for removable dentures is much better than using acrylic resin. This because the alloys have almost no destructive influence over the dentures bearing area. Due to the precise way it is made, the stability of shape, the lack of internal stresses and the close contact with the dentures bearing area, it is possible to achieve very good retention of the denture over a long span of time. Another advantage is that the metal framework conducts temperature changes and this facilitates keeping the tissues in good health. Also, a denture metal framework makes it much easier for the patient to maintain good oral hygiene by lowering the risk of plaque accumulation. However, a metal framework has a disadvantage as well - prosthesis relining cannot be made.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Completely edentulous maxillary and mandibular ridges\n2. Healthy mucosa and absence of remaining roots\n3. Good physical and mental health\n4. Willing to give informed consent\n5. Normal maxilla-mandibular relationship Angle Class I\n6. Adequate bone quality and quantity in terms of width and height in the anterior maxillary mandibular ridges verified by preoperative cone beam CT\n7. Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses\n\nExclusion Criteria:\n\n1. Uncontrolled diabetes\n2. Smoking habits\n3. Radiotherapy\n4. Clinical or radiographic signs of pathologic conditions\n5. Osteoporosis\n6. Patients on corticosteroids\n7. Bruxism'}, 'identificationModule': {'nctId': 'NCT05466305', 'briefTitle': 'Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Immunological and Microbiological Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate', 'orgStudyIdInfo': {'id': '01012336911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Maxillary complete denture reinforced by chrome cobalt alloy', 'description': 'Completely edentulous patients treated by maxillary complete denture reinforced by chrome cobalt alloy', 'interventionNames': ['Device: Gold plated chrome cobalt alloy']}, {'type': 'EXPERIMENTAL', 'label': 'Maxillary complete denture reinforced by gold plated chrome cobalt alloy', 'description': 'Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy', 'interventionNames': ['Device: Gold plated chrome cobalt alloy']}], 'interventions': [{'name': 'Gold plated chrome cobalt alloy', 'type': 'DEVICE', 'otherNames': ['Completely edentulous patients treated by maxillary complete denture reinforced by gold plated chrome cobalt alloy'], 'description': 'Acrylic resin complete denture having a metal chrome cobalt palatal plate which plated by gold', 'armGroupLabels': ['Maxillary complete denture reinforced by chrome cobalt alloy', 'Maxillary complete denture reinforced by gold plated chrome cobalt alloy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shady M. El Naggar, PhD', 'role': 'CONTACT', 'email': 'shady.mahmoud@buc.edu.eg', 'phone': '01122110085'}], 'overallOfficials': [{'name': 'Shady M. El Naggar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Badr University in Cairo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Shady El Naggar', 'investigatorAffiliation': 'Badr University'}}}}