Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-27 @ 11:37 AM
Study NCT ID:
NCT05615051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Implant Surface Decontamination on the Reconstructive Outcomes 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of the disease', 'timeFrame': '12 months', 'description': 'No pocket depth \\>6mm, no bleeding on probing, no suppuration, no progressive bone loss'}], 'secondaryOutcomes': [{'measure': 'Radiographic bone gain and clinical outcomes', 'timeFrame': '12 months', 'description': 'Bone gain and changes in defect angle when compared to baseline radiographic features and evolution of clinical parameters compared to baseline data'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '40693504', 'type': 'DERIVED', 'citation': 'Monje A, Navarro-Mesa S, Soldini C, Zappala G, Pena P, Navarro JM Sr, Pons R. Surface Decontamination on the Reconstructive Therapy of Peri-Implantitis: A Multicenter Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70075. doi: 10.1111/cid.70075.'}]}, 'descriptionModule': {'briefSummary': 'Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)\n\n* Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes\n* Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.\n\nThe infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.\n* All patients in age of 18 to 80\n* non-smokers\n* no presence of systemic disease or medication known to alter bone metabolism\n* partial or complete edentulous patients that have no active periodontal disease.\n\nExclusion criteria:\n\n* pregnancy or lactation\n* history of or current smokers\n* uncontrolled medical conditions,\n* lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,\n* advanced(A) peri-implantitis (\\>50% of the implant length).'}, 'identificationModule': {'nctId': 'NCT05615051', 'briefTitle': 'Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis', 'organization': {'class': 'OTHER', 'fullName': 'Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain'}, 'officialTitle': 'Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '31102022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group electrolytic approach (EA)', 'description': 'Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes', 'interventionNames': ['Device: Surface decontamination procedure aiming at reconstructive therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group hydrogen peroxide (HP)', 'description': 'Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze', 'interventionNames': ['Device: Surface decontamination procedure aiming at reconstructive therapy']}], 'interventions': [{'name': 'Surface decontamination procedure aiming at reconstructive therapy', 'type': 'DEVICE', 'otherNames': ['Hydrogen peroxide'], 'description': 'Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis', 'armGroupLabels': ['Group electrolytic approach (EA)', 'Group hydrogen peroxide (HP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06011', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Clinica CICOM', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}