[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621504":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":40,"studyPopulation":34,"armGroups":41,"interventions":54,"overallOfficials":34,"centralContacts":64,"locations":69,"responsibleParty":80,"collaborators":34,"id":84,"slug":34,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":34,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":34,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":108,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Hanoi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in peri-implant soft tissue thickness","Change in peri-implant soft tissue thickness measured using standardized digital methods.","Baseline (before surgery) to 9 months after surgery",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change in width of peri-implant keratinized tissue","Change in the width of keratinized tissue around the implant measured clinically using standardized procedures.","Baseline to 9 months after surgery",{"measure":19,"description":20,"timeFrame":17},"Change in peri-implant marginal bone level","Changes in marginal bone level assessed using cone-beam computed tomography where indicated.",{"measure":22,"description":23,"timeFrame":24},"Peri-implant clinical indices","Assessment of peri-implant inflammation using standardized clinical indices.","Up to 9 months after surgery",[26],{"measure":27,"description":28,"timeFrame":24},"Postoperative complications and adverse events","Incidence of postoperative complications, including soft tissue necrosis, infection, bleeding, implant failure, and other adverse events.",{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":34,"timePerspective":34,"maskingInfo":35},"RANDOMIZED","PARALLEL","Participants are randomly assigned in a 1:1 ratio to one of two parallel groups to receive either a connective tissue graft or a collagen matrix for peri-implant soft tissue augmentation, with no crossover between groups.","TREATMENT",null,{"masking":36,"maskingDescription":37,"whoMasked":38},"SINGLE","Outcome assessment is performed by an independent examiner who is blinded to group allocation.",[39],"OUTCOMES_ASSESSOR","This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.\n\nClinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.\n\nThe study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Connective Tissue Graft (CTG)","ACTIVE_COMPARATOR","Peri-implant soft tissue augmentation using autogenous connective tissue graft.",[47],"Procedure: Connective Tissue Graft",{"label":49,"type":50,"description":51,"interventionNames":52},"Collagen Matrix","EXPERIMENTAL","Peri-implant soft tissue augmentation using a collagen matrix.",[53],"Device: Collagen Matrix",[55,59],{"type":56,"name":49,"description":57,"armGroupLabels":58,"otherNames":34},"DEVICE","A porcine-derived collagen matrix is used for peri-implant soft tissue augmentation at the time of implant surgery, serving as a substitute for autogenous connective tissue grafting.",[49],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":34},"PROCEDURE","Connective Tissue Graft","An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.",[43],[65],{"name":66,"role":67,"phone":34,"phoneExt":34,"email":68},"Phu Manh Nguyen, DDS, MSc","CONTACT","manhphu@hmu.edu.vn",[70],{"facility":5,"status":34,"city":71,"state":34,"zip":34,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":34},"Hanoi","Vietnam","VN",{"type":75,"coordinates":76},"Point",[77,78],105.84117,21.0245,{"lat":78,"lon":77},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","DUC NGUYEN MINH","DDS","100621504",false,"NCT07371481","CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation","Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area","Inclusion Criteria:\n\nAdults aged 18 to 65 years.\n\nPatients requiring dental implant treatment in the mandibular molar region.\n\nPresence of insufficient peri-implant soft tissue thickness (\\\u003C 2 mm).\n\nAdequate general health to undergo minor oral surgery.\n\nAbility and willingness to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\nSystemic conditions or medications that may impair wound healing.\n\nHeavy smoking (more than 10 cigarettes per day).\n\nHistory of allergy or hypersensitivity to collagen-based materials.\n\nPrevious graft failure or complications at the intended implant site.\n\nLoss of three or more adjacent teeth in the study area (excluding third molars).","ALL","18 Years","65 Years",{"count":94,"type":95},46,"ESTIMATED","INTERVENTIONAL",[98],"NA","This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery.\n\nThe study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.",[101,102],"Peri-implant Soft Tissue Deficiency","Insufficient Peri-implant Keratinized Tissue",[104,105,106,107],"Peri-implant soft tissue augmentation","Connective tissue graft","Collagen matrix","Dental implant","NOT_YET_RECRUITING","2026-01-27",{"date":111,"type":112},"2026-01-29","ACTUAL",{"date":114,"type":95},"2026-02",{"date":116,"type":95},"2028-12",{"name":5,"class":6},1]