[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659697":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":37,"studyPopulation":25,"armGroups":38,"interventions":48,"overallOfficials":25,"centralContacts":25,"locations":58,"responsibleParty":76,"collaborators":25,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":25,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":102,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"bone fill\u002Fgain","by paralleling periapical technique, evaluate amount of bone fill","6 months",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Clinical Attachment Level Gain","Clinical attachment level will be assessed using periodontal probing",{"measure":18,"description":19,"timeFrame":20},"Severity Of Adverse Effect","the severity of adverse effects will be assessed using a visual analog scale (VAS)","Days 0, 3, 5, and 7 after surgical procedure",{"measure":22,"description":23,"timeFrame":24},"Local Soft Tissue Healing Score","Local soft tissue healing will be assessed using the healing index (HI)","2 and 4 weeks after the surgical procedure",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":32},"QUADRUPLE",[33,34,35,36],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Patients are diagnosed as periodontitis Stage ( III,IV) Grade (A,B,C) with infra-bony periodontal defect in the bone wall of two or three osseous wall estimated by radiographic evaluation and patients not responding to S1 and S2 there is residual pockets ≥4 mm with bleeding on probing or presence of deep periodontal pockets ≥6 mm, full mouth plaque score and bleeding on probing score ≤ 20% , only vital teeth involved, thick gingival biotype more than 1 mm with enough width of attached gingiva\n\nAccording to S3 EFP guidelines S1 and S2 done with Supra-gingival dental biofilm control, improving the effectiveness of oral hygiene, the selected patients will be assigned to complete full mouth non-surgical periodontal treatment, which include supra-gingival scaling, subgingival root planning and curettage with ultrasonic instruments and manual instrumentation with Gracey curettes, with using adjunctive local antibiotics .Patients will be advised to perform regular oral hygiene and to use mouthwash with chlorhexidine twice a day for a week. The patients will be reminded every 2 days and informed of the appropriate instructions for the complete mechanical control of the plaque, which consisted of brushing with a soft toothbrush with a roller technique and cleaning interdentally with dental floss. Supra-gingival plaque removal will be performed when necessary.\n\nAfter 4-6 weeks, patients will be re-examined to ensure indication of periodontal surgery after initial therapy.\n\nPatients who refer to S3 divided into subgroups:\n\nGroup I: 11 patients with infra-bony periodontal defects will receive beta -tricalcium phosphate (β-TCP) scaffold followed by collagen membrane coverage Group II: 11 patients with infra-bony periodontal defects will receive gingival mesenchymal stem cells derived small extracellular vesicles on the β-TCP scaffold and covered by a collagen membrane.",[39,44],{"label":40,"type":41,"description":25,"interventionNames":42},"arm 1 include 11 patients","ACTIVE_COMPARATOR",[43],"Biological: Gingival mesenchymal stem cell derived small extracellular vesicles",{"label":45,"type":41,"description":25,"interventionNames":46},"arm 2 control group include 11 patients",[47],"Other: β-calcium triphosphate (β-TCP) + collagen membrane",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":25},"BIOLOGICAL","Gingival mesenchymal stem cell derived small extracellular vesicles","gingival sample will be taken from the patient and cultured for small extracellular vesicles extraction and then will be carried on a B-TCP scaffold covered by collagen membrane inserted into infra-bony periodontal defect in the same patient for arm group 1",[40],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":25},"β-calcium triphosphate (β-TCP) + collagen membrane","in patients with infra-bony periodontal pockets will be received beta tricalcium phosphate scaffold covered by collagen membrane as a control group",[45],[59],{"facility":60,"status":25,"city":61,"state":25,"zip":25,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Faculty of Dentistry Ain Shams University","Cairo","Egypt","EG",{"type":65,"coordinates":66},"Point",[67,68],31.24967,30.06263,{"lat":68,"lon":67},[71],{"name":72,"role":73,"phone":74,"phoneExt":25,"email":75},"Manar R Mehanny, BDS","CONTACT","01110367866","manar27ramadan@gmail.com",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Manar Ramadan","teaching assistant at periodontology department at BUC University in Cairo","100659697","phase-2-effect-of-gingival-mesenchymal-stem-cell-derived-small-extracellular-vesicles-in-management-of-infra-bony-periodontal-defect-100659697",false,"NCT07867067","Effect of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defect","Adjunctive Use of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defects: A Randomized Controlled Clinical Trial","Inclusion Criteria\n\n1. Healthy Individuals\n2. Non-smokers\n3. Presence of interproximal defect in the bone wall of two or three osseous estimated by periapical radiographic evaluation and probing depth ≥6 mm after S1 and S2 therapy\n4. Loss of clinical attachment ≥4 mm after S1 and S2 treatment\n5. Full mouth plaque score and bleeding on probing score ≤20% after S1 and S2 therapy\n6. Only vital teeth involved\n7. Thick gingival biotype more than 1 mm with enough width of attached gingiva.\n\n   * Exclusion Criteria:\n\n(a) Pregnant and lactating females. (b) Non-cooperating patients. Individuals with decision problems (prisoners, disabled, and mentally retarded patients)","ALL","20 Years","40 Years",{"count":91,"type":92},22,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The goal of the study to evaluate whether the adjunctive use of gingival mesenchymal stem cell-derived extracellular vesicles (GMSC-derived EVs) combined with β-tricalcium phosphate (β-TCP) and a collagen membrane results in superior radiographic bone fill compared to β-TCP and collagen membrane alone in the surgical management of infra-bony periodontal defects over a 6-month follow-up period.",[98,99],"Infra-bony Periodontal Defect","Intra-bony Periodontal Defect",[101],"infra-bony pockets, vertical bone loss, gingival mesenchymal stem cell derived small extracellular vesicles, exosomes","NOT_YET_RECRUITING","2026-10-06",{"date":105,"type":106},"2026-10-09","ACTUAL",{"date":108,"type":92},"2026-10-01",{"date":110,"type":92},"2027-11-01",{"name":5,"class":6},1]