Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT05350293
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000848', 'term': 'Anodontia'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the crestal bone height', 'timeFrame': 'T1:3 months after cementation, T2: 6 months after cementation, T3: 1 year after cementation', 'description': 'It Is the loss of bone that occurred around the dental implant neck after fixing the final prosthesis (abutment and crown).\n\nA periapical radiograph is going to be taken using a digital intra-oral sensor with a special holder in a parallel way, to measure the changes that occurred at the level of the bone around the implant depending on MBLS concept taking two referring points from the neck of the abutment to the first match of the bone with the abutment using special programs on computer (Photoshop) during different periods.'}], 'secondaryOutcomes': [{'measure': 'Change in the depth of periodontal pockets', 'timeFrame': 'T1: direct after cementation, T2:3 months after cementation, T3: 6 months after cementation, T4: 1 year after cementation', 'description': 'Periodontal pockets are spaces surrounding the implant under the gum line. The pocket around the implant will be measured by using special plastic probe slides between the implant and gum to measure the depth of the periodontal pocket, and the changes in the depth of pockets will be noted and register after fixing the final prosthesis (abutment and crown), during different periods.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implant', '3D printed abutment', 'molded abutment'], 'conditions': ['Missing Teeth']}, 'referencesModule': {'references': [{'pmid': '32469723', 'type': 'BACKGROUND', 'citation': 'Barbin T, Veloso DV, Del Rio Silva L, Borges GA, Presotto AGC, Barao VAR, Mesquita MF. 3D metal printing in dentistry: An in vitro biomechanical comparative study of two additive manufacturing technologies for full-arch implant-supported prostheses. J Mech Behav Biomed Mater. 2020 Aug;108:103821. doi: 10.1016/j.jmbbm.2020.103821. Epub 2020 Apr 27.'}, {'pmid': '33114737', 'type': 'BACKGROUND', 'citation': 'Bae S, Hong MH, Lee H, Lee CH, Hong M, Lee J, Lee DH. Reliability of Metal 3D Printing with Respect to the Marginal Fit of Fixed Dental Prostheses: A Systematic Review and Meta-Analysis. Materials (Basel). 2020 Oct 26;13(21):4781. doi: 10.3390/ma13214781.'}, {'pmid': '31027960', 'type': 'BACKGROUND', 'citation': 'Jang Y, Sim JY, Park JK, Kim WC, Kim HY, Kim JH. Accuracy of 3-unit fixed dental prostheses fabricated on 3D-printed casts. J Prosthet Dent. 2020 Jan;123(1):135-142. doi: 10.1016/j.prosdent.2018.11.004. Epub 2019 Apr 23.'}, {'pmid': '33284906', 'type': 'BACKGROUND', 'citation': 'Ramalho I, Witek L, Coelho PG, Bergamo E, Pegoraro LF, Bonfante EA. Influence of Abutment Fabrication Method on 3D Fit at the Implant-Abutment Connection. Int J Prosthodont. 2020 Nov/Dec;33(6):641-647. doi: 10.11607/ijp.6574.'}, {'pmid': '34529710', 'type': 'BACKGROUND', 'citation': 'Chou WT, Chuang CC, Wang YB, Chiu HC. Comparison of the internal fit of metal crowns fabricated by traditional casting, computer numerical control milling, and three-dimensional printing. PLoS One. 2021 Sep 16;16(9):e0257158. doi: 10.1371/journal.pone.0257158. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Compare two different types of abutments (molded abutments and computer-designed 3D printed abutments) in terms of the amount of bone loss, and depth of periodontal pockets around the implant during different periods.', 'detailedDescription': 'In the past few years, the number of research conducted on the designs of abutments and materials has increased. Often, the restoration is done over the implant using standard abutments that the implant company prefabricated, but due to the problems facing the dentist from the occurrence of bone absorption, an increase in the depth of the pocket after restoration, other types of abutment design methods have been introduced as needed (molded abutment made by lost wax technique and computer-designed abutment made using a 3D laser printer), those customised abutments were made special for each patient depending on their conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient's age is greater than 20 years and younger than 50\n* Good oral health\n* Absence of systemic diseases that may affect the healing of surrounding tissues, such as diabetes.\n\nExclusion Criteria:\n\n* The presence of non-functional habits such as stridor\n* Acute or acute periodontitis, previous loss of implants\n* Poor general health conditions\n* Previous radiotherapy in the head and neck area\n* Mental incompetence\n* Orthodontic treatment"}, 'identificationModule': {'nctId': 'NCT05350293', 'briefTitle': 'Evaluation of the Abutment Type Following Oral Implants in Terms of the Surrounding Bone Height', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Evaluation of Two Different Types of Abutments on Post-prosthesis Bone Resorption: A Randomized Controlled Clinical and Radiological Trial', 'orgStudyIdInfo': {'id': 'UDDS-Ortho-08-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Molded abutment', 'description': 'A plastic abutment that is provided by the implant manufacturer will be used. This abutment will be modified using wax, and then it will be dismantled, wedged, and poured using a Ni-Cr mixture. A plastic abutment that the implant manufacturer provides will be used. This abutment will be modified using wax, and then it will be dismantled, wedged, and poured using a Ni-Cr mixture.', 'interventionNames': ['Other: Molded abutment']}, {'type': 'EXPERIMENTAL', 'label': '3D printed abutment', 'description': 'The customised abutment will be made using a laser printer with a Cr-Co mixture after being designed using a special computer program.', 'interventionNames': ['Other: 3D printed abutment']}], 'interventions': [{'name': 'Molded abutment', 'type': 'OTHER', 'description': 'The waxed plastic abutment will dismantle, wedged, and poured using a Ni-Cr mixture then it will be trimmed to make it ready to make the permanent restoration over it.\n\nThe prostheses will be cemented above the abutment using dual-cure resin cement then the final restoration (crown and abutment) will be fixed using a screw-retained manner.', 'armGroupLabels': ['Molded abutment']}, {'name': '3D printed abutment', 'type': 'OTHER', 'description': 'A marker or Scan body appropriate for the type of implant will be placed on the laboratory implant substitute, a digital scan of the marker will be done in the lab, and the scanned image will be transferred to a computer design software where the prosthesis is designed, In the printing phase, the final prosthesis will be manufactured using a stepwise metal powder supply and a laser fusion process. Making the abutment ready to make the permanent restoration over it. The prostheses will be cemented above the abutment using dual-cure resin cement then the final restoration (crown and abutment) will be fixed using a screw-retained manner.', 'armGroupLabels': ['3D printed abutment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', 'country': 'Syria', 'facility': 'University of Damascus', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Mohammad Anas Almodalal, DDS,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of fixed prosthodontics , Damascus University, Syria'}, {'name': 'Mohammad Luai Morad, DDS,MSc,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of fixed prosthodontics , Damascus University, Syria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}