[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626797":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Harvard Medical School (HMS and HSDM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Autogenous gingival graft\u002F free gingival graft (FGG)","ACTIVE_COMPARATOR","the area will receive conventional gingival augmentation procedure with use of autogenous gingival graft\u002F free gingival graft (FGG)",[13],"Other: Autogenous gingival graft",{"label":15,"type":16,"description":17,"interventionNames":18},"Starmatrix collagen membrane","EXPERIMENTAL","the area will receive conventional gingival augmentation procedure with use of Starmatrix collagen membrane",[19],"Device: Starmatrix collagen membrane",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Our study will test a new, ready-to-use collagen membrane called Star Matrix as an alternative for the conventional surgery that takes a strip of a patient's own tissue from the roof of the mouth (an autogenous gingival graft) to augment thin or missing gum.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Autogenous gingival graft","gingival insufficiency will be treated with autogenous gingival graft",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"David Kim, DDS, DMSc","CONTACT","(617) 432-1434","dkim@hsdm.harvard.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"Harvard Dental Center","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","David Kim","Associate Professor","100626797","star-matrix-vs-autogenous-graft-for-gingival-augmentation-split-mouth-rct-100626797",false,"NCT07440303","Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT","The Clinical Efficacy of Star Matrix Versus Autogenous Gingival Graft in Augmenting Keratinized Tissue Around Teeth- A Split-mouth Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Adults 20 - 80 years old who need gingival augmentation on both sides of the lower jaw.\n* Able and willing to sign the consent form, follow study instructions and return for all visits\n* Generally healthy (no significant illnesses or medicines that could interfere with healing).\n* Demonstrates good daily oral hygiene (low plaque levels at baseline).\n\nExclusion Criteria:\n\n* Does not meet any of the inclusion points or is unlikely to follow the schedule\n* Previous gingival graft at the study site that failed\n* Needs a root-coverage (recession-repair) procedure instead of simple width augmentation\n* Active, untreated gum disease, cavities, infection, or chronic inflammation near the study teeth\n* Used cigarettes, e-cigarettes, or other nicotine products within 3 weeks\n* Insulin-dependent diabetes or hemoglobin A1c \\> 6.5 %\n* Cancer (other than minor skin cancers or in-situ cervical cancer) within the past 5 years\n* Currently pregnant or breastfeeding\n* Taking (or soon to begin) drugs that change bone turnover (e.g., bisphosphonates, steroids)\n* Diseases that disturb bone metabolism (except common osteoporosis)\n* Auto-immune disease or known allergy to porcine collagen or study materials\n* Active infection at the planned graft site\n* Current use of systemic blood thinners (anticoagulants or antiplatelet agents; e.g., warfarin, heparin\u002FLMWH, DOACs such as apixaban\u002Frivaroxaban\u002Fdabigatran\u002Fedoxaban, or P2Y12 inhibitors such as clopidogrel\u002Fprasugrel\u002Fticagrelor)",true,"ALL","20 Years","80 Years",{"count":67,"type":68},12,"ESTIMATED","INTERVENTIONAL",[71],"NA","This split-mouth randomized controlled clinical trial will test whether a ready-to-use collagen membrane (Star Matrix) can widen the protective band of gum tissue (keratinized gingiva) as effectively as the standard free gingival graft harvested from the palate.\n\nCentral question Can Star Matrix provide the same or better gain in keratinized tissue width-with less patient discomfort and chair-time-than an autogenous graft?\n\nPrimary objectives\n\nCompare the 6-month increase in keratinized tissue width between Star Matrix and autogenous graft sites.\n\nAssess patient-reported pain and morbidity associated with each treatment.\n\nSecondary objectives\n\nMeasure operative time, early healing scores, esthetic outcomes, and (optional) histologic quality of the regenerated tissue.\n\nMethods Twelve adults with ≤ 2 mm keratinized tissue on contralateral lower-jaw teeth will be enrolled. Each participant receives Star Matrix on one side and a conventional free gingival graft on the other. Follow-up visits at 2, 4, 8, 12 and 24 weeks include clinical measurements, standardized photographs, and a 7-day postoperative pain diary. An optional 2 mm punch biopsy at 6 months is analyzed microscopically.",[74,75],"Lack of Keratinized Gingiva","Mucogingival Deformity - Insufficient Keratinized Tissue",[77],"mucogingival deformity","2026-02-23",{"date":80,"type":81},"2026-02-27","ACTUAL",{"date":83,"type":81},"2025-11-06",{"date":85,"type":68},"2026-10-01",{"name":5,"class":6},1]