[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626056":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Universidad Complutense de Madrid","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Theravex Oral and Theravex Tissue Care Plus","EXPERIMENTAL","Subjects receive a Modified Free Gingival Graft (M-FGG). Immediately after graft harvesting, 0.5 ml of Theravex Tissue Care Plus is applied to the graft for 5 minutes. Before graft placement, 0.5 ml of the solution is applied to the recipient site. Post-surgically, patients rinse with 5 ml of Theravex Oral for 30 seconds immediately after surgery, followed by twice-daily rinsing for 14 days",[13,14],"Procedure: Modified Free Gingival Graft (M-FGG)","Drug: Theravex Bioactive Solutions (Tissue Care Plus and Oral)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Subjects receive the same Modified Free Gingival Graft (M-FGG) surgical procedure. In place of the active agent, the graft is submerged in a blinded saline solution (placebo), and the recipient site is irrigated with the same placebo. Post-surgically, patients rinse with a blinded 0.05% cetylpyridinium chloride solution twice daily for 2 weeks.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Modified Free Gingival Graft (M-FGG)","The surgical procedure is performed under local anesthesia. It begins with an intrasulcular incision at the gingival margin of the recession, followed by 2 mm-long horizontal incisions at the cementoenamel junction (CEJ) and diverging vertical releasing incisions. A thin partial-thickness flap is raised and excised to prepare the recipient area.\n\nA connective tissue pedicle flap is then outlined apical to the exposed root, dissected from the periosteum, flipped, and anchored over the root surface using absorbable sutures. Subsequently, a free gingival graft (1.5-2 mm thick) is harvested from the palatal premolar\u002Fmolar area. This graft is placed over the recipient site and secured to the periosteum with simple interrupted and cross mattress sutures to ensure complete stability.",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Theravex Bioactive Solutions (Tissue Care Plus and Oral)","Active Ingredients: A novel bioactive saline solution containing calcium chloride and magnesium dichloride hexahydrate.\n\nIntraoperative Application: Immediately after harvesting the free gingival graft (1.5-2 mm thickness), 0.5 ml of Theravex Tissue Care Plus is applied to the graft and left to soak for 5 minutes.\n\nRecipient Site Treatment: Before placing the graft, 0.5 ml of the solution is applied directly to the prepared recipient site.\n\nPostoperative Protocol: Patients perform an immediate post-surgical rinse with 5 ml of Theravex Oral for 30 seconds. Starting the day after surgery, patients rinse twice daily with Theravex Oral for a duration of 2 weeks.",[9],[33],"Bone Bioactive Liquid (BBL)",[35],{"name":36,"affiliation":5,"role":37},"Mariano Sanz Alonso, DMD, MD, PHD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":26,"email":42},"CONTACT","913942021","marsan@ucm.es",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Andrea Dobos, DMD","+36309532140","andobos@ucm.es",[48],{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Complutense University of Madrid","RECRUITING","Madrid","28040","Spain","ES",{"type":56,"coordinates":57},"Point",[58,59],-3.70256,40.4165,{"lat":59,"lon":58},[62],{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[66],{"name":67,"class":68},"Biointelligent Technology Systems SL","INDUSTRY","100626056","theravex-oral-and-theravex-tissue-care-plus-in-the-healing-process-of-mucogingival-surgery-100626056",false,"NCT07430670","Theravex Oral and Theravex Tissue Care Plus in the Healing Process of Mucogingival Surgery","Clinical Study on the Efficacy of Theravex Oral and Theravex Tissue Care Plus in Periodontal Surgery\" Modified Free Gingival Graft for the Treatment of RT1-RT2: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Healthy patients aged ≥ 18 years.\n* Patients with at least one mandibular incisor presenting a gingival recession RT1-RT2 and requiring a free gingival graft.\n* Periodontal health in either an intact or reduced periodontium (Chapple et al., 2018) with a plaque index ≤ 20% (O'Leary et al., 1972).\n* Initial probing depth ≤ 3 mm in the treated teeth.\n* No dental mobility (grade ≤ 1) in the treated teeth.\n* Well-defined CEJ\n* Agreement to take part in this study (signed informed consent).\n\nExclusion Criteria:\n\n* Smokers ≥10 cigarettes\u002Fday.\n* Patients treated with Theravex \\[IS1.1\\]\\[ma1.2\\]previously.\n* Untreated parafunctional habits.\n* Restorations that cannot be removed for proper treatment.\n* Pregnant patients or cases with uncertain pregnancy status (self-reported).\n* Patients with uncontrolled systemic diseases, neurological, psychiatric disorders, or other known conditions capable of influencing the results of the study.\n* Patients not attending follow-ups or not signing informed consent.","ALL","18 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"NA","This clinical study assesses the efficacy of two novel bioactive solutions, Theravex Oral and Theravex Tissue Care Plus, in enhancing soft tissue healing after periodontal surgery. The study focuses on patients undergoing a Modified Free Gingival Graft (M-FGG) technique to treat gingival recessions around mandibular incisors. Participants are randomly assigned to a test group receiving the Theravex treatment or a control group receiving a saline placebo. The primary goal is to measure the impact of these solutions on root coverage and other key outcomes, such as tissue gain, color integration, and postoperative pain, over a one-year period.",[86],"Gingival Recession, Localized",[88,23,89,90,91,92,93,94,95,96],"Gingiva Recession","Theravex (Oral and Tissue Care Plus)","Bone Bioactive Liquid","Root Coverage","Soft Tissue Healing","Neovascularization","Spectrophotometry","Ultrasonography","Randomized Clinical Trial (RCT)","2026-02-17",{"date":99,"type":100},"2026-02-24","ACTUAL",{"date":97,"type":100},{"date":103,"type":80},"2027-07-06",{"name":5,"class":6},1]