Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06028867
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], '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', 'CARE_PROVIDER'], 'maskingDescription': 'Sealed envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subgingival biofilm', 'timeFrame': '2 weeks', 'description': 'Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.', 'detailedDescription': 'Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.\n\nExclusion Criteria:\n\n* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.\n* Pregnancy.\n* Systemic diseases.'}, 'identificationModule': {'nctId': 'NCT06028867', 'briefTitle': 'Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '121-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine 0,12% + Sodium DNA mouthwash', 'description': 'Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine 0,20% mouthwash', 'description': 'Patients are treated with a mouthwash containing Chlorhexidine 0,20%', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo mouthwash', 'description': 'Patients are treated with a placebo mouthwash', 'interventionNames': ['Procedure: Non-surgical periodontal treatment']}], 'interventions': [{'name': 'Non-surgical periodontal treatment', 'type': 'PROCEDURE', 'description': 'Subgingival biofilm ultrasonic debridement', 'armGroupLabels': ['Chlorhexidine 0,12% + Sodium DNA mouthwash', 'Chlorhexidine 0,20% mouthwash', 'Placebo mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'country': 'Italy', 'facility': 'AOU Policlinico G. Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}