Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-27 @ 5:23 AM
Study NCT ID:
NCT06366295
Status:
UNKNOWN
Last Update Posted:
2024-04-17
First Post:
2024-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial
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', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgingival plaque pathogens (Aa, Pg, Td) levels', 'timeFrame': '0 (before) and 6 months after SRP', 'description': 'Levels of periodontal pathogens (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola) measured with real-time polymerase chain reaction (RT-PCR) test; data presented as number of bacteria of these species and percentage of total bacteria found in a sample; sample taken from the deepest pocket on each side.'}, {'measure': 'Gingival crevicular fluid levels of cytokines', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Levels of (IL - interleukin) IL-1β, IL-6, IL-8, IL-10 and interferon-gamma in gingival crevicular fluid presented as pg/ml; sample taken from the deepest pocket on each side.'}], 'primaryOutcomes': [{'measure': 'Probing pocket depth (PPD)', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Distance from the gingival margin to the bottom of the gingival sulcus'}, {'measure': 'Clinical attachment level (CAL)', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Distance from the cementoenamel junction to the bottom of the gingival sulcus'}, {'measure': 'Bleeding on probing (BoP)', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.'}, {'measure': 'Plaque index (PI)', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Percentage of sites with plaque'}], 'secondaryOutcomes': [{'measure': 'Width of keratinized tissue (KTW)', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Distance between the most apical point of gingival margin and the mucogingival junction'}, {'measure': 'Gingival thickness (GT)', 'timeFrame': '0 (before), 3 and 6 months after SRP', 'description': 'Thickness of the gingiva measured 2 mm apical to the gingival margin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontal endoscopy, perioscopy'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.', 'detailedDescription': 'Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20-60; (II)\n* preserved lateral and anterior teeth;\n* no periodontal treatment in the last 12 months;\n* intermediate or advanced periodontitis (Stage II / III / IV)\n* in each quadrant at least three teeth with PPD\\>5 mm after initial treatment (scaling, motivation, instruction)\n\nExclusion Criteria:\n\n* antibiotic therapy in the last 6 months;\n* smoking;\n* systemic diseases affecting periodontal tissues;\n* pregnancy or lactation;\n* orthodontic treatment;\n* tooth mobility II / III degree;\n* involvement of third degree furcations according to Hamp classification;\n* endodontic issues'}, 'identificationModule': {'nctId': 'NCT06366295', 'briefTitle': 'Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'WUM.Perio.05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subgingival mechanotherapy with perioscopy', 'description': 'Scaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface.', 'interventionNames': ['Device: subgingival mechanotherapy with perioscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classical subgingival mechanotherapy', 'description': 'Scaling and root planing using ultrasonic scaler and curettes.', 'interventionNames': ['Device: classical subgingival mechanotherapy']}], 'interventions': [{'name': 'subgingival mechanotherapy with perioscopy', 'type': 'DEVICE', 'description': 'Subgingival mechanotherapy using a machine scaler, curettes and a perioscope', 'armGroupLabels': ['Subgingival mechanotherapy with perioscopy']}, {'name': 'classical subgingival mechanotherapy', 'type': 'DEVICE', 'description': 'Subgingival mechanotherapy using a machine scaler and curettes', 'armGroupLabels': ['Classical subgingival mechanotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Bartlomiej Gorski, DDS, PhD', 'role': 'CONTACT', 'email': 'bartlomiej.gorski@wum.edu.pl', 'phone': '+48 22 502 20 99'}], 'facility': 'Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Karolina Grzywacka', 'role': 'CONTACT', 'email': 'k.grzywacka@gmail.com', 'phone': '+48796137960'}, {'name': 'Bartlomiej Górski, PhD', 'role': 'CONTACT', 'email': 'bartlomiej.gorski@wum.edu.pl', 'phone': '+48 22 116 64 31'}], 'overallOfficials': [{'name': 'Bartlomiej Górski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}