[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655459":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":54,"studyPopulation":43,"armGroups":55,"interventions":77,"overallOfficials":95,"centralContacts":105,"locations":115,"responsibleParty":139,"collaborators":43,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":150,"minAge":151,"maxAge":43,"enrollmentInfo":152,"targetDuration":43,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":165,"overallStatus":118,"whyStopped":43,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Universidad del Desarrollo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Alveolar Ridge Dimensions","Change in hard- and soft-tissue dimensions of the extraction site between baseline (T1) and 12 weeks after tooth extraction (T3), assessed through three-dimensional volumetric analysis using superimposed CBCT and intraoral scan datasets. Hard-tissue measurements include horizontal ridge width at 1, 3, and 5 mm apical to the alveolar crest (HW-1, HW-3, HW-5), buccal plate width, and socket depth. Soft-tissue measurements include tissue thickness at 1, 3, and 5 mm apical to the alveolar crest (TH-1, TH-3, TH-5) and total occlusal soft-tissue height.","12 weeks after tooth extraction",[14,17,21,25,29,33,37,40],{"measure":15,"description":16,"timeFrame":12},"Histomorphometric Bone Formation","Percentage of newly formed bone, residual biomaterial, and connective tissue\u002Fmarrow spaces measured in bone biopsy specimens obtained during implant placement.",{"measure":18,"description":19,"timeFrame":20},"Postoperative Pain","Patient-reported postoperative pain assessed using a 100-mm Visual Analogue Scale (VAS).","21 days after tooth extraction",{"measure":22,"description":23,"timeFrame":24},"Postoperative Complications","Frequency and severity of soft-tissue dehiscence, membrane exposure or displacement, localized infection, and uncontrolled acute pain.","Up to 12 weeks after tooth extraction",{"measure":26,"description":27,"timeFrame":28},"Keratinized Tissue Width","Change in the width of keratinized tissue measured clinically in millimeters.","Baseline to 12 weeks after tooth extraction",{"measure":30,"description":31,"timeFrame":32},"Oral Health-Related Quality of Life","Change in Oral Health Impact Profile (OHIP-14) scores between baseline and definitive implant-supported restoration.","Baseline to 24-28 weeks after tooth extraction",{"measure":34,"description":35,"timeFrame":36},"Bleeding on probing","Percentage of peri-implant sites presenting bleeding on probing.","12 and 24 months after implant loading",{"measure":38,"description":39,"timeFrame":36},"Peri-implant probing depth","Mean peri-implant probing depth measured in millimeters using a calibrated periodontal probe.",{"measure":41,"description":42,"timeFrame":36},"Radiographic marginal bone level","Mean marginal bone level measured radiographically in millimeters around implants.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel treatment groups: spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with L-PRF, or autologous blood clot with L-PRF and d-PTFE membrane. Each participant will receive only the assigned intervention and will remain in the same study group throughout the study. Outcomes will be assessed at predefined follow-up intervals up to 24 months after implant loading.","TREATMENT",{"masking":50,"maskingDescription":51,"whoMasked":52},"SINGLE","Outcome assessors responsible for volumetric, radiographic, and histomorphometric analyses will be blinded to treatment allocation. Due to the nature of the surgical interventions, participants and treating clinicians cannot be blinded to group assignment.",[53],"OUTCOMES_ASSESSOR","Alveolar ridge dimensional changes following tooth extraction are a well-documented biological phenomenon that may compromise future implant placement and prosthetic rehabilitation. These alterations are primarily associated with physiological bone modeling and remodeling processes, particularly affecting the buccal bone plate, which is often thin and highly susceptible to post-extraction resorption.\n\nAlveolar ridge preservation (ARP) procedures have been developed to reduce post-extraction hard- and soft-tissue volume loss. Numerous techniques have been described, including the use of barrier membranes, platelet concentrates, and grafting materials. However, substantial controversy remains regarding the necessity of membrane utilization, the role of leukocyte- and platelet-rich fibrin (L-PRF), and the optimal approach for maintaining alveolar ridge dimensions while minimizing treatment complexity and costs.\n\nDense polytetrafluoroethylene (d-PTFE) membranes have been proposed as an effective barrier for preserving extraction socket architecture, whereas L-PRF has been suggested to enhance soft-tissue healing and tissue regeneration through the release of autologous growth factors. Despite the widespread clinical use of both approaches, evidence comparing these treatment strategies remains limited.\n\nThis randomized controlled clinical trial aims to compare four post-extraction socket management protocols: spontaneous healing, autologous blood clot combined with a d-PTFE membrane, autologous blood clot combined with L-PRF, and autologous blood clot combined with both L-PRF and a d-PTFE membrane. The study will evaluate their effects on hard- and soft-tissue dimensional preservation, clinical healing, postoperative outcomes, histomorphometric bone formation, patient-reported quality of life, and long-term implant-related outcomes.\n\nThe findings of this study are expected to contribute to the development of evidence-based protocols for alveolar ridge preservation and to improve clinical decision-making in implant dentistry.",[56,62,68,73],{"label":57,"type":58,"description":59,"interventionNames":60},"Spontaneous Healing","ACTIVE_COMPARATOR","Following atraumatic tooth extraction, the socket is left to heal spontaneously without the use of alveolar ridge preservation materials or barrier membranes.",[61],"Procedure: Spontaneous Healing",{"label":63,"type":64,"description":65,"interventionNames":66},"Arm 2: Blood Clot + d-PTFE Membrane","EXPERIMENTAL","Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to promote alveolar ridge preservation.",[67],"Procedure: d-PTFE Membrane",{"label":69,"type":64,"description":70,"interventionNames":71},"Arm 3: Blood Clot + L-PRF","Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) in combination with the natural blood clot to support tissue healing and alveolar ridge preservation.",[67,72],"Procedure: Leukocyte- and Platelet-Rich Fibrin (L-PRF)",{"label":74,"type":64,"description":75,"interventionNames":76},"Blood Clot + L-PRF + d-PTFE Membrane","Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) and covered with a dense polytetrafluoroethylene (d-PTFE) membrane to enhance tissue healing and alveolar ridge preservation.",[72],[78,84,88],{"type":79,"name":57,"description":80,"armGroupLabels":81,"otherNames":82},"PROCEDURE","Following atraumatic tooth extraction, the extraction socket is left to heal naturally without the use of alveolar ridge preservation materials, grafting biomaterials, platelet concentrates, or barrier membranes. Healing occurs through spontaneous blood clot formation and physiological post-extraction tissue repair.",[57],[83],"Unassisted Socket Healing",{"type":79,"name":85,"description":86,"armGroupLabels":87,"otherNames":43},"d-PTFE Membrane","Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to protect the socket and support alveolar ridge preservation during healing",[63,69],{"type":79,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Leukocyte- and Platelet-Rich Fibrin (L-PRF)","Autologous leukocyte- and platelet-rich fibrin (L-PRF) prepared from the participant's peripheral blood and placed within the extraction socket to promote tissue healing and support alveolar ridge preservation through the sustained release of growth factors.",[69,74],[93,94],"L-PRF","Platelet-Rich Fibrin",[96,99,102],{"name":97,"affiliation":5,"role":98},"Francisca c Collao, DDS","STUDY_DIRECTOR",{"name":100,"affiliation":5,"role":101},"Claudio M Miranda, dds","PRINCIPAL_INVESTIGATOR",{"name":103,"affiliation":5,"role":104},"Dusan M Marinkovic, DDS","STUDY_CHAIR",[106,111],{"name":107,"role":108,"phone":109,"phoneExt":43,"email":110},"Claudio M Claudio Miranda, DDS, Director","CONTACT","+56 (2) 2327 9110","clmirandacar@gmail.com",{"name":112,"role":108,"phone":113,"phoneExt":43,"email":114},"Dusan M Dusan Marinkovic, DDS","+56 (2) 2327 5256","dusan.marinkovic@udd.cl",[116],{"facility":117,"status":118,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"Universidad del Desarrollo (UDD)","RECRUITING","Santiago","Santiago Metropolitan","7610315","Chile","CL",{"type":125,"coordinates":126},"Point",[127,128],-70.64827,-33.45694,{"lat":128,"lon":127},[131,133,134,136,138],{"name":132,"role":108,"phone":109,"phoneExt":43,"email":110},"Claudio m Claudio miranda, dds",{"name":103,"role":108,"phone":109,"phoneExt":43,"email":114},{"name":135,"role":101,"phone":43,"phoneExt":43,"email":43},"Claudio M Miranda, DDS",{"name":97,"role":137,"phone":43,"phoneExt":43,"email":43},"SUB_INVESTIGATOR",{"name":103,"role":137,"phone":43,"phoneExt":43,"email":43},{"type":140,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100655459","volumetric-efficacy-of-alveolar-ridge-preservation-100655459",false,"NCT07812883","Volumetric Efficacy of Alveolar Ridge Preservation","Comparative Efficacy of Three Alveolar Ridge Preservation Techniques for Volumetric Tissue Maintenance Following Tooth Extraction","ARP","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Requirement for tooth extraction with the possibility of subsequent implant-supported rehabilitation in the maxillary or mandibular premolar or molar regions.\n* Extraction sockets classified as Class I to Class Va according to the modified Cardaropoli classification.\n* American Society of Anesthesiologists (ASA) Physical Status I or II.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Current treatment with bisphosphonates or systemic corticosteroids.\n* History of head and neck radiotherapy.\n* Metabolic bone disorders.\n* Teeth presenting with acute infectious pathology at the time of extraction.\n* Pregnancy or breastfeeding.\n* Inability or unwillingness to attend scheduled follow-up visits.\n* Any medical or psychological condition that, in the opinion of the investigators, could interfere with study participation or data interpretation.",true,"ALL","18 Years",{"count":153,"type":154},70,"ESTIMATED","INTERVENTIONAL",[157],"NA","The goal of this clinical trial is to compare the effectiveness of four post-extraction socket management approaches in preserving alveolar ridge dimensions following tooth extraction in adults requiring implant-supported rehabilitation in posterior regions.\n\nThe main questions it aims to answer are:\n\n* Which treatment approach provides the greatest preservation of hard- and soft-tissue dimensions 12 weeks after tooth extraction?\n* Does the use of a dense polytetrafluoroethylene (d-PTFE) membrane improve alveolar ridge preservation compared with approaches that do not use a membrane?\n* Are there differences among the treatment groups regarding postoperative healing, complications, pain, and bone regeneration?\n\nResearchers will compare spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with leukocyte- and platelet-rich fibrin (L-PRF), and autologous blood clot with L-PRF plus d-PTFE membrane to determine which approach provides the best preservation of alveolar ridge dimensions and tissue healing.\n\nParticipants will:\n\n* Undergo tooth extraction and be randomly assigned to one of four treatment groups.\n* Receive clinical examinations, intraoral scans, photographs, and cone-beam computed tomography (CBCT) imaging at scheduled follow-up visits.\n* Complete assessments of postoperative pain and oral health-related quality of life.\n* Undergo implant placement 12 weeks after tooth extraction, including collection of a bone biopsy for histomorphometric analysis.\n* Attend follow-up visits to evaluate peri-implant tissue health, marginal bone stability, and implant success up to 24 months after implant loading.",[160,161,162,163,164],"Alveolar Ridge Preservation","Tooth Loss","Tooth Extraction","Tooth Extraction Site Healing","Alveolar Ridge Resorption After Extraction",[160,162,166,167,85,168,169,93,170],"Extraction Socket","Socket Preservation","Dense Polytetrafluoroethylene Membrane","Leukocyte- and Platelet-Rich Fibrin","Randomized Controlled Trial","2026-09-04",{"date":173,"type":174},"2026-09-10","ACTUAL",{"date":176,"type":154},"2026-09-15",{"date":178,"type":154},"2028-10-01",{"name":5,"class":6},1]