Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT06125418
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2023-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone
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', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients in each group will received different types of customized healing abutment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'soft tissue alteration', 'timeFrame': 'T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up', 'description': 'peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points'}, {'measure': 'hard tissue alteration', 'timeFrame': 'T0 baseline before implant placement, 6month follow up, 12month follow up', 'description': 'peri-implant marginal bone change compared to baseline at different time points by periapical radiograph'}, {'measure': 'volumetric alteration', 'timeFrame': 'T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up', 'description': 'peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan'}], 'secondaryOutcomes': [{'measure': 'pain numerical rating scale', 'timeFrame': 'at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery', 'description': 'pain assessment at time of final prosthesis delivery with scale from 0 to 10'}, {'measure': 'pink esthetic score', 'timeFrame': 'T0 baseline before implant placement, 6 month follow up', 'description': 'pink esthetic score change compared to before implant treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental implant, customized healing abutment'], 'conditions': ['Peri-implant Tissue Response With Use of Customized Healing Abutments']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:\n\n• effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.', 'detailedDescription': 'Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age;\n* patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions\n* sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;\n* had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.\n\nExclusion Criteria:\n\n* medical and general contraindications for the surgical procedure;\n* heavy smokers (\\>10 cigarettes/day);\n* an active infection at the implant site.'}, 'identificationModule': {'nctId': 'NCT06125418', 'briefTitle': 'Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone', 'orgStudyIdInfo': {'id': '43/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Customized group', 'description': 'patients who received customized healing abutments following implant placement. customized healing abutments will be fabricated with different macrogeometry and different emergence angle', 'interventionNames': ['Procedure: customized healing abutment']}, {'type': 'EXPERIMENTAL', 'label': 'Standard group', 'description': 'patients who received standard titanium healing abutments following implant placement', 'interventionNames': ['Procedure: standard healing abutment']}], 'interventions': [{'name': 'customized healing abutment', 'type': 'PROCEDURE', 'description': 'patients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.', 'armGroupLabels': ['Customized group']}, {'name': 'standard healing abutment', 'type': 'PROCEDURE', 'description': 'patients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.', 'armGroupLabels': ['Standard group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50300', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Prosthodontics, Faculty of Dentistry, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Pimduen Rungsiyakull, AssocProfDr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Pimduen Rungsiyakull', 'investigatorAffiliation': 'Chiang Mai University'}}}}