[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629407":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":37,"studyPopulation":28,"armGroups":38,"interventions":56,"overallOfficials":69,"centralContacts":78,"locations":84,"responsibleParty":100,"collaborators":28,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":28,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":28,"enrollmentInfo":113,"targetDuration":28,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":131,"whyStopped":28,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"El Mobadder, Marwan, Ph.D., DDS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Probing Pocket Depth (PPD)","Probing Pocket Depth is the distance, measured in millimeters, from the gingival margin (the edge of the gum tissue) to the bottom of the periodontal pocket, which is the point where the soft tissue attaches to the tooth. It is measured using a calibrated periodontal probe at six sites per tooth: mesiobuccal, mid-buccal, distobuccal, mesiolingual\u002Fpalatal, mid-lingual\u002Fpalatal, and distolingual\u002Fpalatal.","pre-operative and at 3 months post-operative",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Plaque index (Silness et Loe)","The Plaque Index is a clinical measure of dental plaque accumulation on the surfaces of teeth. Each selected tooth surface is scored from 0 to 3 based on the thickness and visibility of plaque:\n\n0: No plaque.\n\n1. A thin film of plaque adhering to the free gingival margin and adjacent tooth surface, only visible after running a probe across the surface.\n2. Moderate accumulation of plaque within the gingival pocket or on the tooth surface, visible to the naked eye.\n3. Abundant plaque accumulation within the gingival pocket and\u002For on the tooth and gingival margin.\n\nIn this study, PI will be recorded on four surfaces (mesial, distal, buccal, and lingual) of selected teeth (#16, #12, #24, #36, #32, #44). Scores for each tooth are summed and divided by the number of surfaces examined to obtain the mean PI, which reflects overall oral hygiene status.","pre-operative and 3 months post-operative",{"measure":19,"description":20,"timeFrame":17},"Bleeding on probing (BOP)","Bleeding on Probing is a clinical measure of gingival inflammation. A periodontal probe is gently inserted into the gingival sulcus or periodontal pocket at six sites per tooth (mesiobuccal, mid-buccal, distobuccal, mesiolingual\u002Fpalatal, mid-lingual\u002Fpalatal, distolingual\u002Fpalatal).\n\nScoring: Each site is recorded as positive if bleeding occurs within 15 seconds after probing, and negative if no bleeding occurs.\n\nThe percentage of bleeding sites is calculated for each participant.\n\nTimepoints: Measured at baseline (T0) and 3 months post-treatment (T3) to assess changes in gingival inflammation following therapy.",{"measure":22,"description":23,"timeFrame":17},"gingival recession","Gingival Recession is the distance, in millimeters, from the cementoenamel junction (CEJ) to the free gingival margin.\n\nMeasurement: Taken at six sites per tooth using a calibrated periodontal probe.\n\nInterpretation: A positive value indicates that the gingival margin is apical (toward the root) relative to the CEJ.\n\nGingival recession reflects loss of soft tissue coverage and is often associated with periodontal disease progression.",{"measure":25,"description":26,"timeFrame":27},"Clinical attachment level","Clinical Attachment Level is a measure of periodontal tissue support and combines pocket depth and gingival recession.\n\nMeasurement: CAL is calculated as:\n\nIf gingival margin is at the CEJ: CAL = Probing Pocket Depth (PPD)\n\nIf gingival margin is apical to CEJ (recession): CAL = PPD + GR\n\nIf gingival margin is coronal to CEJ: CAL = PPD - distance from CEJ to gingival margin\n\nSignificance: CAL reflects the true attachment loss and is a key parameter for diagnosing and monitoring periodontitis.","Measured at baseline (T0) and 3 months post-treatment (T3).",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"RANDOMIZED","PARALLEL","The trial has three parallel arms: standard care, standard care plus sodium hypochlorite\u002Famino acid gel, and standard care plus sodium hypochlorite\u002Famino acid gel + cross-linked hyaluronic acid (\"Clean and Seal\" protocol). Participants remain in their assigned group for the duration of the study.","TREATMENT",{"masking":35,"maskingDescription":36,"whoMasked":28},"NONE","Not applicable; all procedures are open-label.","Detailed Description\n\nThis study is a randomized controlled clinical trial designed to evaluate the effectiveness of adjunctive therapies in the non-surgical treatment of periodontitis. The trial compares three groups:\n\nStandard non-surgical periodontal therapy (scaling and root planing with oral hygiene instruction).\n\nAdjunctive sodium hypochlorite\u002Famino acid gel applied before mechanical debridement.\n\nAdjunctive sodium hypochlorite\u002Famino acid gel followed by cross-linked hyaluronic acid (\"Clean and Seal\" protocol) after mechanical debridement.\n\nThe study aims to assess whether the use of these adjunctive treatments provides additional clinical benefits beyond standard therapy, measured through periodontal parameters such as plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR).\n\nParticipants will be recruited from patients attending a dental clinic in Antwerp, Belgium. Randomization will be conducted at the time of enrollment using a pre-defined allocation scheme implemented in Microsoft Excel. Treatments will be performed by qualified dental professionals under standardized clinical conditions. Clinical measurements will be collected before intervention and at three months post-intervention by a calibrated examiner.\n\nThe trial is designed to provide robust clinical evidence regarding the efficacy and safety of sodium hypochlorite\u002Famino acid gel alone and in combination with cross-linked hyaluronic acid as adjuncts to conventional non-surgical periodontal therapy. Findings may inform future clinical practice and contribute to optimizing non-surgical treatment protocols for periodontitis.",[39,45,51],{"label":40,"type":41,"description":42,"interventionNames":43},"Control group","ACTIVE_COMPARATOR","Participants receive standard care, including oral hygiene instructions, supragingival and subgingival mechanical debridement using ultrasonic and hand instruments, and brief irrigation with 0.12% chlorhexidine solution. No adjunctive sodium hypochlorite or hyaluronic acid is used.",[44],"Procedure: Standard Non-Surgical Periodontal Therapy",{"label":46,"type":47,"description":48,"interventionNames":49},"Standard Therapy + Sodium Hypochlorite\u002FAmino Acid Gel","EXPERIMENTAL","Participants receive the same standard care as Arm 1. In addition, a 0.9% sodium hypochlorite\u002Famino acid gel (Perisolv) is instilled into periodontal pockets with probing depth \\>4 mm and left for 60 seconds before mechanical debridement. The gel application is repeated as needed until instrumentation is complete.",[50],"Procedure: tandard Therapy + Sodium Hypochlorite\u002FAmino Acid Gel",{"label":52,"type":47,"description":53,"interventionNames":54},"Standard Therapy + Sodium Hypochlorite\u002FAmino Acid Gel + Cross-Linked Hyaluronic Acid","Participants receive the same treatment as Arm 2. After instrumentation, cross-linked hyaluronic acid gel (Hyadent BG) is applied to the treated pockets to promote healing and tissue regeneration, following the \"Clean and Seal\" protocol.",[55],"Procedure: Standard Therapy + Sodium Hypochlorite\u002FAmino Acid Gel + Cross-Linked Hyaluronic Acid",[57,62,66],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":28},"PROCEDURE","Standard Non-Surgical Periodontal Therapy","Standard Non-Surgical Periodontal Therapy based on the American Academy of Periodontology's guidelines: mechanical debridement with manual and ultrasonics",[40],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":28},"tandard Therapy + Sodium Hypochlorite\u002FAmino Acid Gel","Participants receive the same standard care as Arm 1. In addition, a 0.9% sodium hypochlorite\u002Famino acid gel is instilled into periodontal pockets with probing depth \\>4 mm and left for 60 seconds before mechanical debridement. The gel application is repeated as needed until instrumentation is complete.",[46],{"type":58,"name":52,"description":67,"armGroupLabels":68,"otherNames":28},"Participants receive the same treatment as Arm 2. After instrumentation, cross-linked hyaluronic acid gel is applied to the treated pockets to promote healing and tissue regeneration, following the \"Clean and Seal\" protocol.",[52],[70,74],{"name":71,"affiliation":72,"role":73},"Marwan El Mobadder, Doctor Ph.D","Department of Periodontology, Faculty of dental medicine, Lebanese University","STUDY_DIRECTOR",{"name":75,"affiliation":76,"role":77},"Kinga Grzech-Lesiniak, Ph.D (doctor)","Dental Surgery Department, Wroclaw Medical University","STUDY_CHAIR",[79],{"name":80,"role":81,"phone":82,"phoneExt":28,"email":83},"Marwan El Mobadder, doctor (Ph.D)","CONTACT","+33658940326","mobader.dds@gmail.com",[85],{"facility":86,"status":28,"city":87,"state":88,"zip":28,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Dental Specialist' DS","Sidon","South of Lebanon","Lebanon","LB",{"type":92,"coordinates":93},"Point",[94,95],35.37148,33.55751,{"lat":95,"lon":94},[98],{"name":99,"role":81,"phone":82,"phoneExt":28,"email":83},"Marwan El Mobadder, Doctor (Ph.D)",{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Marwan El Mobadder","Principal Investigator, Specialist in Periodontal and Implant Therapies","100629407","non-surgical-treatment-of-periodontitis-with-adjunctive-sodium-hypochloriteamino-acids-and-cross-linked-hyaluronic-acid-100629407",false,"NCT07474272","Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite\u002FAmino Acids and Cross-Linked Hyaluronic Acid","Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite \u002FAmino Acids and Cross-Linked Hyaluronic Acid: Randomized Controlled Trial","Inclusion Criteria:\n\n* Localized periodontal pocket with a probing depth ≥ 6 mm and a clinical - attachment loss of \\> 3 mm (periodontitis stage III or IV; classification of the European Federation of Periodontology and American Academy of Periodontology);\n* Patients who signed the written informed consent and is willing to cooperate;\n* Bleeding on probing in more than 30% of the sites.\n\nExclusion Criteria:\n\n* Medical history likely to affect periodontal status and\u002For to compromise treatment outcomes;\n* Patients who received antibiotic and\u002For anti-inflammatory treatments the last 6 months\n* Patients who received immunosuppressors treatments the last 6 months;\n* Patients who received any periodontal therapy for the last 6 months;\n* Pregnant or lactating women;\n* Smokers smoking more than 10 cigarettes per day.","ALL","16 Years",{"count":114,"type":115},78,"ESTIMATED","INTERVENTIONAL",[118],"NA","The goal of this clinical trial is to learn if using sodium hypochlorite\u002Famino acid gel, with or without cross-linked hyaluronic acid, as an addition to standard non-surgical periodontal therapy works to treat periodontitis in adults. It will also learn about the safety of these treatments. The main questions it aims to answer are:\n\nDoes the adjunctive treatment reduce bleeding on probing, plaque index, and periodontal pocket depth?\n\nWhat medical or dental problems do participants have when receiving these treatments?\n\nResearchers will compare:\n\nStandard non-surgical periodontal therapy alone\n\nStandard therapy plus sodium hypochlorite\u002Famino acid gel\n\nStandard therapy plus sodium hypochlorite\u002Famino acid gel and cross-linked hyaluronic acid (\"Clean and Seal\" protocol)\n\nParticipants will:\n\nReceive their assigned treatment during one clinical session per the study protocol\n\nHave clinical measurements taken before treatment and at three months after treatment\n\nBe monitored for any dental or medical adverse events related to the procedures",[121],"Periodontitis",[123,124,125,126,127,128,129,130],"periodontal pocket","periodontitis","periodontal disease","deep periodontal pocket","localized periodontitis","generalized periodontitis","non-surgical treatment of periodontitis","non-surgical periodontal treatment","NOT_YET_RECRUITING","2026-03-14",{"date":134,"type":135},"2026-03-17","ACTUAL",{"date":137,"type":115},"2026-03-11",{"date":139,"type":115},"2026-08",{"name":102,"class":6},1]