Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-29 @ 12:27 AM
Study NCT ID:
NCT06131567
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trials with paired number of subjects'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of disease resolution', 'timeFrame': '12 months after surgery', 'description': 'pocket depth \\<6mm, no bleeding on probing, no suppuration, no progressive bone loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* All patients in age of 18 to 80, non-smokers\n* With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.\n* Peri-implantitis defined according to the EFP/AAP consensus meeting\n* Combined defect configuration\n\nExclusion criteria:\n\n* Pregnancy or lactation\n* History of or current smokers\n* Uncontrolled medical conditions,\n* Cement-retained restoration\n* Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.'}, 'identificationModule': {'nctId': 'NCT06131567', 'briefTitle': 'Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis', 'organization': {'class': 'OTHER', 'fullName': 'Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain'}, 'officialTitle': 'Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '18102021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantoplasty', 'description': 'Implantoplasty to all the implant surface', 'interventionNames': ['Procedure: Implantoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Implantoplasty on the supracrestal component', 'description': 'Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide', 'interventionNames': ['Procedure: Implantoplasty']}], 'interventions': [{'name': 'Implantoplasty', 'type': 'PROCEDURE', 'description': 'Implantoplasty as surface decontamination method', 'armGroupLabels': ['Implantoplasty', 'Implantoplasty on the supracrestal component']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06011', 'city': 'Badajoz', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alberto Monje, DDS, MS', 'role': 'CONTACT', 'email': 'amonjec@umich.edu'}, {'name': 'Alberto Monje, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Implantologia Cirugia Oral y Maxilofacial', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}], 'centralContacts': [{'name': 'Mamen Tome Rincon, DH', 'role': 'CONTACT', 'email': 'mtome@periocicom.com', 'phone': '+34924203045'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head', 'investigatorFullName': 'Alberto Monje', 'investigatorAffiliation': 'Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain'}}}}