Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 10:19 AM
Study NCT ID:
NCT06684769
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D017823', 'term': 'Furcation Defects'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised, single-blinded, split-mouth clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-09', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Bleeding on Probing index (mBoP)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Pseudo marker of inflammation, lower scores mean a better outcome 0 = no bleeding;\n\n1. = a bleeding spot;\n2. = a bleeding line;\n3. = pronounced bleeding within 30 seconds following probing of the pocket'}, {'measure': 'Probing Pocket Depth (PPD) in mm', 'timeFrame': 'Baseline,12 weeks', 'description': 'Pseudo marker of inflammation, lower scores mean a better outcome.'}, {'measure': 'Clinical Attachment Level (CAL) in mm', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Marker of gain in attachment, lower scores mean a better outcome'}, {'measure': 'Furcation Involvement 1', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Marker of gain in attachment, Horizontal Furcation involvement measurement using Nabers Probe\n\n1. Horizontal loss of periodontal tissue support less than 3 mm\n2. Horizontal loss of support 3 mm or more, but not encompassing the total width of the furcation\n3. Horizontal through-and-through destruction of the periodontal tissue in the furcation Lower scores mean a better outcome'}, {'measure': 'Furcation Involvement 2 in mm', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Marker of gain in attachment, Horizontal Furcation involvement measurement using UNC 15mm probe, lower scores mean a better outcome'}], 'secondaryOutcomes': [{'measure': 'Proteomic profile of gingival crevicular fluid (GCF)', 'timeFrame': 'Baseline, 4 weeks,', 'description': 'Differences in the GCF of regeneration-related marker concentrations between test and control groups'}, {'measure': 'Microbiological changes in microbial plaque', 'timeFrame': 'Baseline, 4 weeks,', 'description': 'Differences in the microbial profile between test and control groups'}, {'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Baseline', 'description': 'Evaluation of self-perceived pain using a 100 mm Visual analog scale (range 0 - 100) at baseline treatment visit; 0 - no pain, 100 - worst pain ever felt. Lower scores mean a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis, Adult', 'Furcation Defects', 'Furcation of Root of Tooth', 'Periodontitis Complex']}, 'descriptionModule': {'briefSummary': "Patients diagnosed with stage III or IV periodontitis who exhibit mandibular first or second molars with Class II, Subclass A, or B buccal and/or lingual mandibular furcation defects (horizontal probing depth of ≥ 3 mm ) will be recruited.\n\nPatients diagnosed with stage III or IV periodontitis who exhibit maxillary first or second molars with Class II, Subclass A, or B buccal furcation defects (horizontal probing depth of ≥ 3 mm ) if furcation involvement on the palatal side (mesiopalatal and distopalatal) does not exceed Class 1 will be recruited.\n\nThis study will be a prospective, randomized, single-blinded, controlled clinical trial with a split-mouth design.\n\nPatients will be recruited from the clinics of the Riga Stradiņš University Institute of Stomatology of Riga, Latvia.\n\nBefore the baseline treatment, all patients who meet the inclusion criteria will be given detailed oral hygiene instructions and motivation.\n\nPatients' furcation defects in each quadrant will be randomly allocated at a 1:1 ratio to either the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives (test group) or Oscillating Chitosan Brush alone (control group).\n\nNon-surgical periodontal treatment of furcation defects on the test side will be performed through the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives and on the control side with Oscillating Chitosan Brush alone.\n\nThe re-evaluation of periodontal status will be performed 12 weeks following the baseline treatment.\n\nBiofilm samples and gingival crevicular fluid (GCF) samples will be taken at the baseline and at 4 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. The patient is 18 years of age or older\n2. The patient does not have any systemic diseases that may affect the results of the study\n3. The patient has a plaque index of 20% or less at the study entry\n4. The patient has a history of severe localized or generalized periodontitis (stage III or IV)\n5. Completed the first and second steps of periodontal treatment (According to Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline) (Sanz M. et al.)\n6. Buccal and/or lingual Class 2A and/or 2B furcation involvement (FI) defects on both sides of the Mandibular first and/or second molars after completing the first and second steps of periodontal treatment.\n7. Buccal Class 2A and/or 2B furcation involvement (FI) defects on both sides of the maxillary first and/or second molars after completion of the first and second step of periodontal treatment if furcation involvement on the palatal side (mesiopalatal and distopalatal) does not exceed Class 1.\n8. Psychological appropriateness\n9. Consents to all follow-up visits\n\nExclusion Criteria:\n\n1. Patients who have systemic diseases that may affect the results of the study\n2. Use of medications that may affect study results (anti-osteoporotic drugs, statins, corticosteroids, anticoagulants)\n3. Patients who use calcium channel blockers, cyclosporine A or antiepileptic drugs if there are clinically visible hyperplastic changes in the gingival margin.\n4. Patients who have received any type of systemic antibiotics in the last six months prior to the start of the study and patients starting antibiotics during the study\n5. Patients requiring antibiotic premedication prior to periodontal treatment\n6. Oncological disease\n7. Chemotherapy and/or radiotherapy (active or history)\n8. Pregnancy and breastfeeding\n9. Any condition or current treatment which, in the opinion of the investigator and/or consulting physician, may present an unreasonable risk\n10. Psychoemotional disorders and depression\n11. Use of antipsychotic medication or antidepressants\n12. Lack of patient motivation to undertake adequate dental care at home or complete periodontal treatment, patients residing outside Latvia\n13. Molars with combined endodontic-periodontal lesions, active endodontic infection\n14. Prosthetic factors for molars not allowing clinical measurements\n15. Huge restoration or amalgam fillings that could potentially cause fractures or furcation involvement\n16. Enamel pearls or filling or crown margins\n17. Decay or root resorption\n18. Tooth mobility degree 3\n19. Molars in which the gingival margin is positioned apically from the entrance into the furcation area\n20. Clinical attachment level and or pockets mesial and distal to the furcation involvement defect of 6 or more mm\n21. Strong vomiting reflex that would prevent adequate periodontal treatment\n22. People close to the study subjects, work colleagues, relatives, etc.'}, 'identificationModule': {'nctId': 'NCT06684769', 'briefTitle': 'A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations', 'organization': {'class': 'OTHER', 'fullName': 'Riga Stradins University'}, 'officialTitle': 'Non-surgical Treatment of Mandibular and Maxillary Molar Furcations With a Chitosan Brush With Adjunct Enamel Matrix Derivative- a Split-mouth Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2-PĒK-4/659/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chitosan brush with Emdogain FL', 'description': 'Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® and Straumann® Emdogain® FL at Baseline', 'interventionNames': ['Device: Emdogain® FL', 'Device: Labrida BioClean®']}, {'type': 'SHAM_COMPARATOR', 'label': 'Chitosan brush alone', 'description': 'Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® at Baseline', 'interventionNames': ['Device: Labrida BioClean®']}], 'interventions': [{'name': 'Emdogain® FL', 'type': 'DEVICE', 'description': 'Enamel Matrix Derivatives', 'armGroupLabels': ['Chitosan brush with Emdogain FL']}, {'name': 'Labrida BioClean®', 'type': 'DEVICE', 'description': 'Oscillating Chitosan Brush', 'armGroupLabels': ['Chitosan brush alone', 'Chitosan brush with Emdogain FL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riga', 'status': 'RECRUITING', 'country': 'Latvia', 'contacts': [{'name': 'Anete Vaskevica, DDS', 'role': 'CONTACT', 'email': 'anete.vaskevica@rsu.lv', 'phone': '+37120202028'}, {'name': 'Darta E Emulina, DDS', 'role': 'CONTACT', 'email': 'dartaemulina@gmail.com', 'phone': '+37122007988'}, {'name': 'Anete Vaskevica, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Riga Stradins University Institute of Stomatology', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}], 'centralContacts': [{'name': 'Anete Vaškevica, DDS', 'role': 'CONTACT', 'email': 'anete.vaskevica@rsu.lv', 'phone': '+37120202028'}, {'name': 'Dārta E Emuliņa, DDS', 'role': 'CONTACT', 'email': 'dartaemulina@gmail.com', 'phone': '+37122007988'}], 'overallOfficials': [{'name': 'Ilze Akota, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Riga Stradins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riga Stradins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Labrida AS', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lectureur', 'investigatorFullName': 'Anete Vaškevica', 'investigatorAffiliation': 'Riga Stradins University'}}}}