[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519783":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":40,"locations":48,"responsibleParty":61,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Autogenous Demineralized Dentin Graft","EXPERIMENTAL","An Autogenous Demineralized Dentin Graft will be prepared from the participant's freshly extracted teeth and placed in the intrabony defect following the modified minimally invasive surgical technique.",[13],"Biological: Autogenous Demineralized Dentin Graft",{"label":15,"type":16,"description":17,"interventionNames":18},"Autogenous bone Graft","ACTIVE_COMPARATOR","An Autogenous Bone Graft will be harvested from the retromolar area and placed in the intrabony defect following the modified minimally invasive surgical technique.",[19],"Biological: Autogenous Bone Graft",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high- speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill. Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid5 for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the intra-bony defect after modified minimally invasive surgical technique.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Autogenous Bone Graft","Modified minimally invasive surgical technique (M-MIST) will be performed in the intra-bony defects, with autogenous bone graft placement. The graft will be harvested from the retromolar area using automatic chip maker (ACM) bur and a hand bone mill will be used to grind the chips into particles, then it will be placed in the defect.",[15],[31,34,37],{"name":32,"affiliation":5,"role":33},"Ghada M. Abouhussein, Bachelor","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":36},"Weam El-Battawy, Ass professor","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":39},"Nesma Shemais, Ass lecturer","STUDY_CHAIR",[41,45],{"name":32,"role":42,"phone":43,"phoneExt":25,"email":44},"CONTACT","+02 01004966156","ghada.mohammed@dentistry.cu.edu.eg",{"name":46,"role":42,"phone":25,"phoneExt":25,"email":47},"Nesma Shemais, Ass Lecturer","nesma.shemais@dentistry.cu.edu.eg",[49],{"facility":50,"status":51,"city":52,"state":25,"zip":25,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":25},"Faculty of Dentistry, Cairo University","RECRUITING","Cairo","Egypt","EG",{"type":56,"coordinates":57},"Point",[58,59],31.24967,30.06263,{"lat":59,"lon":58},{"type":33,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ghada Mohamed Ali Hussein Abouhussein","Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University","100519783","phase-4-evaluation-of-autogenous-demineralized-dentin-graft-vs-autogenous-bone-graft-in-management-of-intrabony-defects-100519783",false,"NCT06048042","Evaluation of Autogenous Demineralized Dentin Graft Vs Autogenous Bone Graft in Management of Intrabony Defects","Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft Versus Autogenous Bone Graft in Management of Periodontal Intrabony Defects Using Modified Minimally Invasive Surgical Technique: A Non-Randomized Clinical Trial","Inclusion Criteria:\n\n* Patient-related criteria:\n\n  * Motivated patient 18 years of age or order.\n  * Patient consulting in the outpatient clinic.\n  * Patient ready to perform oral hygiene instructions.\n  * Provide informed consent.\n  * Accepts the 6 months follow-up period.\n* Teeth related criteria:\n\n  * Tooth with two or three-walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.\n  * Mature permanent tooth.\n  * Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or supernumerary tooth to be extracted and used as whole tooth graft inside the intrabony defect.\n\nExclusion Criteria:\n\n* Patient-related criteria:\n\n  * Medically compromised patients.\n  * Pregnant women.\n  * Uncooperative patients.\n  * Smokers.\n  * Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism).\n  * Failure to maintain good oral hygiene.\n* Teeth related criteria:\n\n  * Teeth with supra-bony defects.\n  * Teeth with grade III mobility.\n  * Teeth having interproximal craters, grade III furcation involvement, and grade III mobility.\n  * Presence of caries or overhanging restorations.\n  * Presence of peri-apical injuries.",true,"ALL","18 Years","50 Years",{"count":76,"type":77},24,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.\n\nThe main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any.\n\nAfter 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements.\n\nCriteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm.\n\nSurgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST).\n\nIntervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth.\n\nControl group: The defect will be filled with autogenous bone graft harvested from the retromolar area.\n\nFor both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.",[83],"Intrabony Periodontal Defect",[83,85,86,87,88],"Demineralized dentin graft","Autogenous bone graft","modified minimally invasive surgical technique","M-MIST","2024-08-23",{"date":91,"type":92},"2024-08-26","ACTUAL",{"date":94,"type":92},"2024-07-17",{"date":96,"type":77},"2025-03",{"name":5,"class":6},1]