[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654591":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":50,"armGroups":51,"interventions":65,"overallOfficials":71,"centralContacts":76,"locations":82,"responsibleParty":98,"collaborators":46,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":46,"enrollmentInfo":110,"targetDuration":46,"studyType":113,"phases":46,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":85,"whyStopped":46,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Plovdiv Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":46},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Change in peri-implant soft-tissue volume","Volumetric change of the peri-implant soft tissue relative to the pre-extraction baseline, measured in cubic millimetres by superimposition of intraoral scans.","Baseline, 3 months after placement (before loading), and 2 weeks after loading",{"measure":14,"description":15,"timeFrame":16},"Time to definitive loading","Interval in months from implant placement to definitive prosthetic loading, determined by the pre-loading radiographic assessment and the implant stability quotient.","Up to 6 months after implant placement",{"measure":18,"description":19,"timeFrame":20},"Implant stability quotient (ISQ)","Implant stability measured by resonance frequency analysis on the ISQ scale from 1 to 100, where higher values indicate greater stability. Stability before loading is the criterion that determines whether the implant is loaded at three months.","At implant placement and at 3 months after placement (before loading)",{"measure":22,"description":23,"timeFrame":24},"Change in alveolar bone volume","Volumetric change of the peri-implant alveolar bone relative to the pre-extraction baseline, measured in cubic millimetres on cone-beam computed tomography.","Baseline and 3 months after placement (before loading)",[26,30,34,38,42],{"measure":27,"description":28,"timeFrame":29},"Early wound healing","Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing.","Days 7 and 14 after surgery",{"measure":31,"description":32,"timeFrame":33},"Analgesic requirement","Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery.","First 5 days after surgery",{"measure":35,"description":36,"timeFrame":37},"Customized healing abutment complications","Number of participants with abutment screw loosening, fracture of the composite healing abutment, or peri-implant infection, each recorded as present or absent.","From surgery to definitive loading, up to 4 months",{"measure":39,"description":40,"timeFrame":41},"Implant survival","Proportion of implants in situ and functional at the latest follow-up visit.","Up to 24 months after implant placement",{"measure":43,"description":44,"timeFrame":45},"Peri-implant bone corticalization","Degree of corticalization of the peri-implant bone, assessed on cone-beam computed tomography using a radiological corticalization index.","3 months after placement (before loading)",null,{"allocation":46,"interventionModel":46,"interventionModelDescription":46,"primaryPurpose":46,"observationalModel":48,"timePerspective":49,"maskingInfo":46},"COHORT","PROSPECTIVE","Consecutive adult patients attending the Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv, with a non-restorable posterior (premolar or molar) tooth indicated for extraction and suitable for immediate implant placement.",[52,57,61],{"label":53,"type":46,"description":54,"interventionNames":55},"Socket class A","Posterior extraction socket in which the interradicular septal bone is sufficient to house the implant, giving circumferential bone contact along its coronal part. Because a molar socket is frequently 10 mm or more across, a residual void commonly remains around the implant within the socket. Participants receive immediate implant placement with a chairside customized healing abutment.",[56],"Procedure: Immediate implant placement with customized healing abutment",{"label":58,"type":46,"description":59,"interventionNames":60},"Socket class B","Posterior extraction socket in which the septal bone is sufficient to stabilise the implant but not to house it, so that part of the implant surface faces the socket rather than bone. Participants receive immediate implant placement with a chairside customized healing abutment.",[56],{"label":62,"type":46,"description":63,"interventionNames":64},"Socket class C","Posterior extraction socket with little or no septal bone, so that primary stability must be obtained from the peripheral socket walls and\u002For the bone apical to the socket. Participants receive immediate implant placement with a chairside customized healing abutment.",[56],[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":46},"PROCEDURE","Immediate implant placement with customized healing abutment","Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone. Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact. No barrier membrane is used. Definitive loading is planned at three months.",[53,58,62],[72],{"name":73,"affiliation":74,"role":75},"Tasho Gavrailov, DMD, PhD","Medical University of Plovdiv","PRINCIPAL_INVESTIGATOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":46,"email":81},"Lyubomir Chenchev, DMD, PhD","CONTACT","+359 887 102 516","lyubomir.chenchev@mu-plovdiv.bg",[83],{"facility":84,"status":85,"city":86,"state":46,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv","RECRUITING","Plovdiv","4000","Bulgaria","BG",{"type":91,"coordinates":92},"Point",[93,94],24.75001,42.15387,{"lat":94,"lon":93},[97],{"name":78,"role":79,"phone":80,"phoneExt":46,"email":81},{"type":99,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100654591","immediate-molar-implants-with-customized-healing-abutments-in-different-post-extraction-socket-classes-100654591",false,"NCT07801573","Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes","Evaluation of the Success of Immediate Implants in the Molar Region Using Individually Fabricated Healing Abutments (Sulcus Formers) in Different Classes of Post-Extraction Sockets: A Prospective Cohort Study","IMPLA-CHA","Inclusion Criteria:\n\n* Age 18 years or over\n* ASA physical status I or II\n* A non-restorable posterior tooth (premolar or molar) indicated for extraction: clinically unrestorable crown, advanced chronic periodontitis, failed or untreatable endodontic therapy, or vertical root fracture\n* Residual bone permitting implant placement with adequate primary stability\n* Able and willing to give written informed consent and to attend the follow-up schedule\n\nExclusion Criteria:\n\n* ASA physical status III or higher\n* Pregnancy or lactation\n* Uncontrolled diabetes mellitus\n* Smoking more than 10 cigarettes per day\n* Drug or alcohol abuse\n* Current or previous bisphosphonate or other antiresorptive therapy\n* Head and neck radiotherapy\n* Immunosuppression\n* Anticoagulant or antiplatelet therapy where the required pre-operative preparation is declined\n* Psychiatric conditions preventing compliance with the study procedures\n* Known titanium allergy\n* Severe bruxism\n* Acute infection at the surgical site\n* Advanced alveolar resorption precluding immediate implant placement","ALL","18 Years",{"count":111,"type":112},60,"ESTIMATED","OBSERVATIONAL","Immediate implant placement into a fresh extraction socket shortens overall treatment time and reduces the number of surgical procedures, but the fit between the implant and the socket walls, and the resulting soft-tissue contour, differ substantially between socket types. This study evaluates immediate implant placement in the molar and posterior region combined with an individually fabricated (customized) healing abutment, or sulcus former, that seals the socket and shapes the emergence profile from the day of surgery.\n\nConsecutive patients with a non-restorable posterior tooth are treated with flapless atraumatic extraction, immediate implant placement, grafting of the residual gap, and a chairside customized healing abutment fabricated on a titanium temporary abutment. Participants are grouped by the class of the post-extraction socket (A, B or C) according to the interradicular septal bone available for primary stability.\n\nOutcomes are preservation of peri-implant soft-tissue volume assessed with an intraoral scanner, preservation of alveolar bone volume assessed on cone-beam computed tomography, implant stability measured by resonance frequency analysis (ISQ) at placement and before loading, and time to definitive loading. Early wound healing on the Landry index, the degree of bone corticalization before loading, implant survival, healing-abutment complications and analgesic requirement are also recorded.",[116,117,118],"Tooth Loss","Alveolar Bone Loss","Jaw, Edentulous, Partially",[120,121,122,123,124,125,126,127,128,129],"immediate implant placement","customized healing abutment","sulcus former","post-extraction socket","socket classification","molar","implant stability quotient","cone-beam computed tomography","peri-implant soft tissue","emergence profile","2026-08-31",{"date":132,"type":133},"2026-09-03","ACTUAL",{"date":135,"type":133},"2024-04-01",{"date":137,"type":112},"2026-12",{"name":5,"class":6},1]