Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-26 @ 10:26 PM
Study NCT ID:
NCT05926557
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All patients are not masked with respect to test and control procedures, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be designed as a double-arm randomized controlled clinical trial. Mucositis will be treated with spermidine gel + non-surgical debridement (NSMD) in Test group and with NSMD alone in Control group. All clinical parameters will be recorded at baseline, 1 and 3 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of BoP (+/-)', 'timeFrame': 'baseline, 1 and 3 months after periodontal therapy', 'description': 'Bleeding on periodontal probing'}], 'secondaryOutcomes': [{'measure': 'Change of Full-mouth Plaque Score (FMPS; %)', 'timeFrame': 'baseline, 1 and 3 months after periodontal therapy', 'description': 'Percentage of all sites exhibiting plaque'}, {'measure': 'Change of Full-mouth Bleeding Score (FMBS; %)', 'timeFrame': 'baseline, 1 and 3 months after periodontal therapy', 'description': 'Percentage of all sites exhibiting bleeding'}, {'measure': 'Change of Probing Depth (PD; millimeters)', 'timeFrame': 'baseline, 1 and 3 months after periodontal therapy', 'description': 'Distance from the gingival margin to the bottom of the peri-implant pocket'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peri-implant Mucositis', 'Spermidine'], 'conditions': ['Peri-implant Mucositis', 'Mucositis Oral']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis. After a meticulous selection, patients will be randomly assigned to Test (spermidine gel + non-surgical debridement) or Control group (non-surgical debridement).', 'detailedDescription': 'Following the recording of the clinical parameters (BoP, FMPS, FMBS, PD), mechanical therapy (NSMD) will be performed in the Test group (spermidine gel) by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle. Control group will instead be treated only through the NSMD.\n\nFinally, after 3 months the clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again and the final evaluation will be performed. Data analysis will be performed using statistical software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Non-smokers and smokers ( ≤ 10 cigarettes/day);\n* Presence of at least 1 implant in mucositis, clinically and radiographically detected;\n* The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown), cemented or screwed.\n\nExclusion Criteria:\n\n* Cancer patients;\n* Periodontally Compromised Patients;\n* Uncontrolled diabetic patients;\n* Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;\n* Pregnant or breastfeeding patients;\n* Implants that support mobile prosthetic products;\n* Implants in peri-implantitis, detected clinically and radiographically.'}, 'identificationModule': {'nctId': 'NCT05926557', 'briefTitle': 'Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel', 'orgStudyIdInfo': {'id': '249/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spermidine Group', 'description': 'Mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the spermidine-based gel will be applied in the peri-implant sulcus using a blunt-tipped needle.', 'interventionNames': ['Procedure: Spermidine gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSMD Group', 'description': 'Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler peek tips.', 'interventionNames': ['Procedure: NSMD']}], 'interventions': [{'name': 'Spermidine gel', 'type': 'PROCEDURE', 'description': 'First step: Non-surgical mechanical debridement (NSMD) Second step: application of spermidine gel', 'armGroupLabels': ['Spermidine Group']}, {'name': 'NSMD', 'type': 'PROCEDURE', 'description': 'Only mechanical debridement with curettes and scaler peek tips', 'armGroupLabels': ['NSMD Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Ramaglia', 'role': 'CONTACT', 'email': 'luca.ramaglia@unina.it', 'phone': '+393476912911'}], 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Luca Ramaglia', 'role': 'CONTACT', 'email': 'luca.ramaglia@unina.it', 'phone': '+393476912911'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Luca Ramaglia', 'investigatorAffiliation': 'Federico II University'}}}}