[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569432":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":69,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Universidad de los Andes, Chile","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"EPP with L-PRF as a filling material","EXPERIMENTAL","This group will have the infrabony defect treated with the use of an EPP minimally invasive technique and the defect will be filled with L-PRF.",[13,14],"Procedure: Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery","Procedure: REGEND001 Autologous Therapy Product",{"label":16,"type":17,"description":18,"interventionNames":19},"EPP with no defect filling material","ACTIVE_COMPARATOR","This group will have the infrabony defect treated with the use of an EPP minimally invasive technique, but the defect will not be filled with L-PRF.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery","The Entire Papilla Preservation Technique (EPP) is a minimally invasive surgical approach for the treatment of intraosseous defects allowing access to the defect maintaining the integrity of the interproximal papilla. Studies have evaluated its efficacy for the regeneration of intraosseous periodontal defects with or without the use of regenerative biomaterials to fill the defect.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"REGEND001 Autologous Therapy Product","L-PRF is an autologous concentrate of platelet- and leukocyte-rich fibrin derived from blood, which through a centrifugation process allows to stimulate, improve and accelerate healing. The growth factors in the concentrates, together with pro-inflammatory and anti-inflammatory molecules, actively participate in the stimulation of the processes associated with tissue and bone repair and regeneration. Due to its high content of fibrin, platelets, leukocytes, monocytes and stem cells, L-PRF acts in immune regulation by controlling inflammation, with a continuous release of growth factors and presents an analgesic effect, which gives greater postoperative comfort to the patient. In addition, being an autologous product, it greatly reduces the risk of infection or rejection by the patient. Due to its beneficial biological effects, low costs and ease of preparation its use as a filling material in intraosseous defects will be evaluated.",[9],[32],{"name":33,"affiliation":34,"role":35},"Andreas G Anwandter, DDS","Universidad de Los Andes","PRINCIPAL_INVESTIGATOR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+56225891100","+562","aanwandter@miuandes.cl",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Antonio Sanz, DDS","+56225891173","asanz@clinicasanz.cl",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"CESA (centro de salud de la clínica odontológica de la Universidad de los Andes)","RECRUITING","Santiago","San Bernardo","8050000","Chile","CL",{"type":56,"coordinates":57},"Point",[58,59],-70.64827,-33.45694,{"lat":59,"lon":58},[62,65,66],{"name":63,"role":38,"phone":39,"phoneExt":40,"email":64},"Guillermo E Salgado, DDS","gsalgado@uandes.cl",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Maria Jose Messina, DDS","SUB_INVESTIGATOR",{"type":70,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100569432","efficacy-of-the-entire-papilla-preservation-technique-with-and-without-the-use-of-l-prf-as-a-regenerative-material-for-the-treatment-of-infrabony-defects-100569432",false,"NCT06694168","Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects","Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with periodontal disease (loss of interproximal clinical attachment loss in 2 non-adjacent teeth or clinical attachment loss of ≥3mm associated with a PD \\>3 mm in two or more teeth) will be included.\n* After re-evaluation (6 weeks after non-surgical periodontal therapy) presented residual probing depths equal to or greater than 6 mm.\n* Residual pocket is associated with interproximal intrabony periodontal defects of at least 2 walls, with a depth ≥ 3 mm and an angulation ≤ 40º determined on a periapical radiograph.\n\nExclusion Criteria:\n\n* Patients with an underlying decompensated pathology such as diabetes and hypertension.\n* Patients taking medications that interfere with the healing process such as bisphosphonates.\n* Patients with diseases that alter bone metabolism such as osteoporosis.\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to evaluate the efficacy of using L-PRF (leukocyte and platelet rich fibrin clot) as an autologous filling material in conjunction with the EPP (entire papilla preservation) technique for the treatment of interproximal intraosseous periodontal defects, compared to the same technique without L-PRF regarding clinical periodontal parameters and obtained radiographic parameters. It will also report possible postoperative complications and evaluate postoperative sensitivity. The main questions it aims to answer is:\n\n• What is the effectiveness of LPR-F in conjunction with a complete papilla preservation (EPP) technique for the treatment of intrabony periodontal defects in CESA (health care center) patients in terms of clinical and radiographic periodontal parameters compared to the use of the same technique without L-PRF?\n\nA non-randomized controlled clinical trial will be conducted on patients at CESA of the Universidad de los Andes. In 30 patients, 30 periodontal defects associated with a pocket with probing depths equal to or greater than 6 mm will be treated using the complete papilla preservation technique, either with L-PRF filling or without any filling material, assigned randomly to each intervention (15 participants in each group). Researchers will evaluate clinical and radiographic parameters at baseline and 6 months post-surgery. Patients will report their level of pain 24 hours and 7 days after surgery.",[88,89,90,91,92,93],"Periodontal Regeneration","Minimally Invasive Surgical Technique","Platelet Rich Fibrin","Microsurgery","Periodontal Intrabony Defect","Periodontal Disease",[95,96,91,97,98,99,100,101],"Periodontitis","Guided Tissue Regeneration","Bone Regeneration","Treatment Outcome","Intrabony defect","minimally invasive surgical technique","Entire papilla preservation","2024-11-20",{"date":104,"type":105},"2024-11-25","ACTUAL",{"date":107,"type":105},"2024-08-27",{"date":109,"type":82},"2026-06-30",{"name":5,"class":6},1]