[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556233":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":73,"collaborators":26,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":26,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Queen Mary University of London","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Group","EXPERIMENTAL","Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.",[13,14],"Combination Product: Hyaluronic Acid (HA) and Octenidine gel","Procedure: Non-surgical periodontal treatment (NSPT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Non-surgical periodontal treatment (NSPT) alone.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Hyaluronic Acid (HA) and Octenidine gel","A thermosensitive gel with Hyaluronic Acid (HA) and Octenidine (Pocket-X®, Geistlich, Wolhusen, Switzerland) will be applied in the periodontal pockets ≥5mm immediately after the subgingival PMPR, by means of a pre-filled syringe bearing a thin plastic tip and following manufacturer's instructions.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Non-surgical periodontal treatment (NSPT)","Full mouth supragingival professional mechanical plaque removal (PMPR) and subgingival PMPR at sites with PPD ≥4mm will be performed with the aid of manual and power-driven instruments under local anaesthesia.",[16,9],[33],{"name":34,"affiliation":35,"role":36},"Jeniffer Perussolo, DDS, MS, PhD","QMUL","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Miljana Bacevic, DDS, PhD","CONTACT","+44 02078823063","BHNT.Clinicaloralresearchcentre@nhs.net",{"name":34,"role":40,"phone":44,"phoneExt":26,"email":45},"02078828641","j.perussolo@qmul.ac.uk",[47,64],{"facility":48,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Centre for Oral Clinical Research (COCR)","RECRUITING","London","E1 2AD","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-0.12574,51.50853,{"lat":58,"lon":57},[61,63],{"name":39,"role":40,"phone":62,"phoneExt":26,"email":42},"+44(0)207 882 6348",{"name":34,"role":40,"phone":44,"phoneExt":26,"email":45},{"facility":65,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"The Royal London Dental Hospital, Barts Health NHS Trust",{"type":55,"coordinates":67},[57,58],{"lat":58,"lon":57},[70,71,72],{"name":39,"role":40,"phone":62,"phoneExt":26,"email":42},{"name":34,"role":40,"phone":44,"phoneExt":26,"email":45},{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":74,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100556233","hyaluronic-acid-and-octenidine-gel-as-an-adjunct-to-non-surgical-periodontal-treatment-100556233",false,"NCT06522438","Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment","Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment","Inclusion Criteria:\n\n* Male or female aged 18 and above\n* Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment, or exhibiting a ≥ 50% reduction in plaque score from the initial screening visit.\n* Periodontitis stage III\u002FIV (grades A to C) with at least one site per quadrant with PPD ≥5mm, bleeding on probing and attachment loss ≥5mm\n* Willing to sign informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Know hypersensitivity and\u002For allergy to any of the product's component (as per user leaflet)\n* Self-reported pregnancy or lactation\n* Smoking (current or in past 5 years), including e-cigarettes\u002Fvaping\n* Medical history including diabetes mellitus or other serious medical\u002F psychiatric conditions or transmittable diseases that according to the investigator may increase the risk associated with study participation\n* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures or\u002Fand systemic antibiotic therapy during the 3 months preceding the baseline evaluation\n* In chronic treatment with anti-inflammatory (including corticosteroids), anticoagulants\u002Fantiplatelets (including aspirin), immunosuppressants or other medication that can severely impact wound healing\n* History of alcohol or drug abuse\n* Subgingival professional mechanical plaque removal (excluding not-extensive subgingival debridement as judged by the examining clinician) and\u002For surgical periodontal treatment within the last 12 months\n* Other severe acute or chronic medical or psychiatric condition or psychological disorder, including limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed, or any additional conditions which, in the judgement of the investigator, would make the subject inappropriate for entry into this trial","ALL","18 Years",{"count":85,"type":86},26,"ESTIMATED","INTERVENTIONAL",[89],"NA","This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. This will be assessed through the expression of specific gingival crevicular fluid markers, as well as by changes in gingival blood flow (assessed by laser speckle contrast imaging), bacterial load, soft tissues contour, clinical parameters and patient-reported outcomes.\n\nThe study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust. Patients will be randomised to receive either NSPT alone or NSPT+ HA and Octenidine gel, and will be followed up to 3 months after treatment.\n\nThe study will consist of 7- 8 visits.",[92,93,94,95,96],"Periodontitis","Wound Heal","Periodontal Pocket","Periodontal Inflammation","Periodontal Attachment Loss",[98,99,100,101],"Hyaluronic Acid","Octenidine","Biomarkers","Non-surgical periodontal treatment","2026-02-03",{"date":104,"type":105},"2026-02-05","ACTUAL",{"date":107,"type":105},"2025-06-03",{"date":109,"type":86},"2027-12-31",{"name":5,"class":6},2]