[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491640":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":62,"responsibleParty":77,"collaborators":36,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":36,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":36,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":101,"whyStopped":36,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"King's College London","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"RCT using hydraulic calcium silicate sealer and L-PRF + GTR","EXPERIMENTAL","Endodontic-periodontal disease patients undergoing root canal treatment using hydraulic calcium silicate sealer and L-PRF + GTR (bone substitute + collagen membrane)",[13],"Procedure: Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR",{"label":15,"type":10,"description":16,"interventionNames":17},"RCT using conventional sealer and L-PRF + GTR","Endodontic-periodontal disease patients undergoing root canal treatment using conventional sealer and L-PRF + GTR (bone substitute + collagen membrane)",[18],"Procedure: Experimental: RCT using conventional sealer and L-PRF + GTR",{"label":20,"type":10,"description":21,"interventionNames":22},"RCT using hydraulic calcium silicate sealer and GTR","Endodontic-periodontal disease patients undergoing root canal treatment using hydraulic calcium silicate sealer and GTR (bone substitute + collagen membrane)",[23],"Procedure: Experimental: RCT using hydraulic calcium silicate sealer and GTR",{"label":25,"type":26,"description":27,"interventionNames":28},"RCT using conventional sealer and GTR (bone substitute + collagen membrane)","ACTIVE_COMPARATOR","Endodontic-periodontal disease patients undergoing root canal treatment using conventional sealer and GTR (bone substitute + collagen membrane)\n\nThis is our control group Both the endodontic and periodontal lesions are managed using gold standard of care biomaterials and techniques",[29],"Procedure: Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Experimental: RCT using hydraulic calcium silicate sealer and L-PRF + GTR","Endodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR +\u002F- LPRF",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Experimental: RCT using conventional sealer and L-PRF + GTR","Endodontic treatment with conventional sealer followed by periodontal treatment with PRF + GTR",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Experimental: RCT using hydraulic calcium silicate sealer and GTR","Endodontic treatment with hydraulic calcium silicate sealer, followed by periodontal surgery using GTR only",[20],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Active Comparator: RCT using conventional sealer and GTR (bone substitute + collagen membrane)","Endodontic treatment with conventional sealer followed by periodontal treatment with GTR only",[25],[50],{"name":51,"affiliation":52,"role":53},"Sadia Niazi","King's College London, London SE1 9RT","PRINCIPAL_INVESTIGATOR",[55,59],{"name":51,"role":56,"phone":57,"phoneExt":36,"email":58},"CONTACT","+44 (0) 2071887459","sadia.niazi@kcl.ac.uk",{"name":60,"role":56,"phone":36,"phoneExt":36,"email":61},"Emily Lu","emily.lu@kcl.ac.uk",[63],{"facility":64,"status":36,"city":65,"state":36,"zip":36,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Guy'S and St Thomas' Nhs Foundation Trust","London","United Kingdom","UK",{"type":69,"coordinates":70},"Point",[71,72],-0.12574,51.50853,{"lat":72,"lon":71},[75,76],{"name":60,"role":56,"phone":36,"phoneExt":36,"email":61},{"name":51,"role":56,"phone":36,"phoneExt":36,"email":58},{"type":78,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100491640","endo-perio-disease---treatment-outcomes-using-conventional-and-hydraulic-calcium-silicate-sealer-with-or-without-lprf-100491640",false,"NCT05681754","Endo-perio Disease - Treatment Outcomes Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF","Endodontic-periodontal Disease - Comparison of Treatment Outcome Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF and Characterisation of Host-microbiome Interaction","Inclusion Criteria:\n\n* • Diagnosis of Endodontic-periodontal disease without root damage in periodontitis patients, Grades I, II, III according to Herrera 2017 classification.\n\n  * Presence of ≥ 1 intrabony defect: interproximal probing pocket depth ≥ 5 mm and ≥ 3mm radiographic intrabony defect, adjacent to single rooted and multi-rooted teeth associated with endodontic-periodontal disease\n  * Age: 18-80\n  * Non-smokers (zero cigarettes within last 5 years)\n\nExclusion Criteria:\n\n* Endodontic considerations: severely sclerosed canals, external cervical resorption and internal root resorption, perforations, root fracture or cracking, re- RCT, apical surgery and unrestorable teeth\n* Teeth with defects not amenable to regeneration or molar teeth planned for root resection\n\n  \\- Periodontal treatment carried out previously to the study site within the last 12 months (excluding not-extensive subgingival debridement as judged by the examining clinician),\n* presence of drug induced gingival overgrowth.\n* Smoking (current or in past 5 years) including e-cigarettes\u002F vaping\n* History of alcohol or drug abuse,\n* Systemic antibiotic therapy during the 3 months preceding the baseline exam,\n* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures,\n* Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam,\n* Medical history of diabetes or transmittable diseases,\n* Chronic inflammatory conditions: chronic peptic ulcer, tuberculosis, rheumatoid arthritis, ulcerative colitis, crohn's disease, active hepatitis, inflammatory bowel diseases, irritable bowel syndrome, autoimmune diseases, liver diseases, renal diseases or cancer\n* Medications which alter bone metabolism: hormone replacement therapy, immunosuppressive drugs, corticosteroids, selective serotonin reuptake inhibitors, tumour necrosis factor blockers, IV bisphosphonates, and\u002For antiresorptive drugs,\n* Self-reported pregnancy or lactation\n* Surgical procedures in the last 6months (any type of surgical procedures)\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation,\n* Poor compliance","ALL","18 Years","80 Years",{"count":90,"type":91},115,"ESTIMATED","INTERVENTIONAL",[94],"NA","The endodontic periodontal-disease is characterized by the involvement of the pulp and periodontal disease in the same tooth. The anatomic connections between the dental pulp and the periodontium provide a pathway for perio-endo communication via apical foramina, lateral canals, exposed dentinal tubules, and developmental grooves. These pathways provide an egress for pulpal disease to affect the periodontium and conversely, an ingress for periodontal disease to affect the pulp.\n\nTeeth with endo-perio disease, which are deemed salvageable might require root canal (endodontic) treatment, followed by staged periodontal treatment. Compared to conventional sealers used for endodontic treatment, the hydraulic calcium silicate based sealers (HCSB)s have excellent sealing ability, biocompatibility, regeneration ability, and antimicrobial characteristics. However little is known about its clinical benefits when used to treat endo-perio disease.\n\nThe gold standard treatment for periodontitis affected teeth associated with intrabony lesions is guided tissue regeneration (GTR) which has significant improved clinical outcomes over open flap debridement (Cochrane systematic review 2005). However, the success the of this regenerative technique requires careful case and defect selection. We propose the use of an autologous bioactive scaffold, leukocyte platelet rich fibrin (L-PRF) to achieve regeneration of periodontal soft and hard tissues, resulting in faster healing, greater bone infill and improved predictability of clinical outcomes",[97,98],"Endodontic Disease","Periodontitis",[100],"Endo-perio lesions","NOT_YET_RECRUITING","2023-01-11",{"date":104,"type":105},"2023-01-12","ACTUAL",{"date":107,"type":91},"2023-05",{"date":109,"type":91},"2033-05",{"name":5,"class":6},1]