Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-01 @ 6:28 AM
Study NCT ID:
NCT06946693
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surface Topography and Color Stability of Conventional, 3D Printed, and Milled Provisional Restorations.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D066330', 'term': 'Printing, Three-Dimensional'}], 'ancestors': [{'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-19', 'studyFirstSubmitDate': '2025-04-19', 'studyFirstSubmitQcDate': '2025-04-19', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.', 'timeFrame': '1 year 6 months', 'description': 'Surface roughness of provisional restorations will be measured using profilometer'}, {'measure': 'Color stability of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.', 'timeFrame': '1 year 6 months', 'description': 'Color stability of provisional restorations will be measured using spectrophotometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PROVISIONAL RESTORATIONS'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'Patient attending the Outdoor Patient Department of the Department of Prosthodontics at Post Graduate Institute of Dental Sciences, Rohtak will be screened. The screening will include history, consent taking and clinical examination of the partially edentulous patients. Patients will be selected according to the inclusion and exclusion criteria. Single stage endosseous implants will be placed. Provisional restorations fabricated by conventional technique, milling, and 3D printing will constitute three groups, followed by evaluation of color stability and surface roughness after intraoral use.', 'detailedDescription': 'Title: "Comparative assessment of the color stability and surface roughness of implant-supported provisional restorations fabricated by conventional technique, milling, and 3D printing: A randomized controlled clinical trial" Rationale: The study needs to verify the color stability and surface roughness of implant-supported provisional restorations fabricated using conventional technique, milling, and 3D printing.\n\nAim and objectives: To evaluate the color stability and surface roughness of implant-supported provisional prosthesis fabricated using conventional technique, milling, and 3D printing in the mandibular posterior region.\n\nSetting: Department of Prosthodontics and Crown \\& Bridge, PGIDS, Rohtak. Study Design: Randomized controlled clinical trial. Population/Participants: Provisional restoration will be fabricated using conventional technique, milling and 3D printing.\n\nSample Size: Total of 36 samples will be prepared (n = 12 samples per test group).\n\nMethodology: This is an in-vivo study and will be carried out in the Department of Prosthodontics and Crown \\& Bridge, Post Graduate Institute of Dental Sciences, Rohtak with the purpose to evaluate the color stability and surface roughness of implant-supported provisional restorations fabricated using conventional technique, milling, and 3D printing in the mandibular posterior region.\n\nOutcome Measures: Measuring the color stability using spectrophotometer and surface roughness using profilometer.\n\nStatistical Analysis: Data obtained will be compiled on MS Office Excel Sheet (v 2010) and will be subjected to statistical analysis using statistical package for social sciences (SPSS v 21.0, IBM). Intergroup and intragroup comparisons will be done according to the distribution of data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Subjects consented to participate in the study. 2. Subjects with maintainable oral hygiene. 3. Subjects with adequate edentulous space at the prospective implant site. 4. Subjects with availability of adequate quantity and quality of bone.\n\n\\-\n\nExclusion Criteria:\n\n1. Subject with presence of infection around proposed site of implant placement.\n2. Subjects with any condition that would interfere with the soft tissue and bone healing.\n3. Subjects in which surgical procedure is contraindicated for any reason.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06946693', 'briefTitle': 'Surface Topography and Color Stability of Conventional, 3D Printed, and Milled Provisional Restorations.', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Comparative Assessment of the Color Stability and Surface Roughness of Implant-Supported Provisional Restorations Fabricated by Conventional Technique, Milling and 3D Printing: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'Dr. NANG NALIKA MOUNGKHOM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'To evaluate the surface roughness and color stability of Conventional provisional restorations', 'interventionNames': ['Procedure: To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'To evaluate the surface roughness and color stability of 3D Printed provisional restorations', 'interventionNames': ['Procedure: To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'To evaluate the surface roughness and color stability of Milled provisional restorations', 'interventionNames': ['Procedure: To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.']}], 'interventions': [{'name': 'To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.', 'type': 'PROCEDURE', 'description': 'Subjects with single stage implant placement and early non-functional loading with implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.', 'armGroupLabels': ['To evaluate the surface roughness and color stability of 3D Printed provisional restorations', 'To evaluate the surface roughness and color stability of Conventional provisional restorations', 'To evaluate the surface roughness and color stability of Milled provisional restorations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'MANU RATHEE, MASTER OF DENTAL SURGERY', 'role': 'CONTACT', 'email': 'ratheemanu@gmail.com', 'phone': '+91 9416141376'}, {'name': 'NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Post Graduate Institute of Dental Sciences', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'centralContacts': [{'name': 'MANU RATHEE, MASTER OF DENTAL SURGERY', 'role': 'CONTACT', 'email': 'ratheemanu@gmail.com', 'phone': '+91 9416141376'}], 'overallOfficials': [{'name': 'NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK, HARYANA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Comparative assessment of the Color Stability and Surface Roughness of Implant-Supported Provisional Restorations Fabricated by Conventional Technique, Milling and 3D Printing: A Randomized Controlled Clinical Trial', 'investigatorFullName': 'Sanjay Tewari', 'investigatorAffiliation': 'Postgraduate Institute of Dental Sciences Rohtak'}}}}