Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT06127069
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized parallel arm clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing Pocket Depth', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months', 'description': 'the distance from the mucosa margin to the bottom of the periodontal pocket'}, {'measure': 'MMP-8', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months', 'description': 'levels of matrix metalloproteinase -8 in gingival crevicular fluid'}], 'secondaryOutcomes': [{'measure': 'Bleeding on Probing', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months', 'description': 'presence or absence of bleeding after probe insertion in the periodontal pocket'}, {'measure': 'Clinical Attachment Level', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months', 'description': 'the distance from cementoenamel junction to the bottom of periodontal pocket'}, {'measure': 'Gingival Recession', 'timeFrame': 'baseline, 6 weeks, 3 months, 6 months', 'description': 'the distance from cementoenamel junction to the mucosa margin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['residual pockets', 'chitosan', 'treatment of periodontitis'], 'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '41201882', 'type': 'DERIVED', 'citation': 'Tseleki G, Batas L, Davidopoulou S, Wohlfahrt JC, Menexes G, Tsalikis L. Management of residual periodontal pockets using an oscillating chitosan device: A randomized clinical trial. J Periodontol. 2025 Nov 7. doi: 10.1002/jper.70010. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study was to investigate the effect of a chitosan brush on the treatment of residual pockets in patients already treated for periodontal disease. Thirty-six patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing, were randomly assigned to two groups. In the test group debridement of residual pockets was performed with ultrasonic scaler and the chitosan brush, whereas in the control group only ultrasonic scalers were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18 or over\n* Subjects diagnosed with chronic periodontitis, Stage III or IV, and had received full mouth scaling and root planning at least three months prior to baseline examination\n* Subjects with at least two residual periodontal pockets of at least 5mm depth that bled on probing\n* Full mouth plaques scores ≤20%\n\nExclusion Criteria:\n\n* Subjects that had received antibiotic therapy 6 months prior to initial examination\n* Subjects with compromised systemic conditions\n* Patients undergoing chemotherapy or radiotherapy\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT06127069', 'briefTitle': 'Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device - A Randomized Parallel Arm Clinical Trial', 'orgStudyIdInfo': {'id': '14/07/2021, 129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chitosan group', 'description': 'debridement of residual periodontal pockets with ultrasonic scaler and the chitosan brush', 'interventionNames': ['Device: chitosan brush', 'Device: ultrasonic scaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'debridement of residual periodontal pockets with ultrasonic scaler only', 'interventionNames': ['Device: ultrasonic scaler']}], 'interventions': [{'name': 'chitosan brush', 'type': 'DEVICE', 'otherNames': ['Labrida BioClean'], 'description': 'debridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes', 'armGroupLabels': ['chitosan group']}, {'name': 'ultrasonic scaler', 'type': 'DEVICE', 'description': 'debridement of periodontal pockets only with ultrasonic scaler', 'armGroupLabels': ['chitosan group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Department of Periodontology, School of Dentistry, Aristotle University of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Lazaros Tsalikis', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, School of Dentistry, Aristotle University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate Student, principal investigator', 'investigatorFullName': 'Georgia Tseleki', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}