[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599760":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Pavia","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sterify Gel + Non-Surgical Therapy","EXPERIMENTAL","This arm receives standard non-surgical peri-implantitis treatment (mechanical debridement, air-polishing with erythritol and glycine) plus the application of Sterify Gel®, a mucoadhesive hydrogel containing polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, applied in the peri-implant pocket using a sterile needle.",[13,14],"Drug: Sterify Gel (mucoadhesive bioactive gel)","Procedure: Standard Non-Surgical Peri-Implantitis Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Non-Surgical Therapy Only","ACTIVE_COMPARATOR","This arm receives standard non-surgical peri-implantitis treatment only, including mechanical debridement with ultrasonic and manual instruments, and air-polishing with erythritol and glycine powders. No adjunctive gel is applied.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sterify Gel (mucoadhesive bioactive gel)","Sterify Gel® is a sterile, ready-to-use mucoadhesive hydrogel formulated with polyvinyl polymers, hydroxytyrosol (a natural antioxidant), magnesium ascorbyl phosphate (a stable vitamin C derivative), and nisin (a naturally occurring antimicrobial peptide). In this study, it is applied into the peri-implant pocket using a 0.6 mm - 23GA sterile needle (Gerhò®) immediately after non-surgical debridement. Application is performed at baseline and at follow-up visits (1, 3, 6, and 9 months). Patients are instructed to avoid rinsing, eating, or using oral hygiene aids at the treated sites for at least 2 hours post-application, and to follow specific hygiene instructions for 48 hours.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Standard Non-Surgical Peri-Implantitis Therapy","Standard therapy consists of supra- and subgingival professional mechanical debridement of peri-implant sites using ultrasonic inserts and manual curettes covered with biocompatible materials (PEEK, teflon, or titanium) to avoid damage to the implant surface. This is followed by air-polishing using erythritol powder (Air-Flow Plus®, EMS; 14 µm) for supragingival biofilm removal and glycine powder (Air-Flow Perio®, EMS; 25 µm) for subgingival polishing. This procedure is repeated at baseline and at 1, 3, 6, and 9 months without the adjunctive use of any topical gel.",[16,9],[33],{"name":34,"affiliation":5,"role":35},"Andrea Scribante, Associate Professor","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+39 0382516223","andrea.scribante@unipv.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia","RECRUITING","Pavia","Lombardy","27100","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],9.15917,45.19205,{"lat":54,"lon":53},[57],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":35,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andrea Scribante","Associate Professor, Principal Investigator","100599760","natural-bioactive-gel-for-peri-implantitis-100599760",false,"NCT07088679","Natural Bioactive Gel for Peri-Implantitis","Efficacy of a Natural Bioactive Gel as an Adjunct to Standard Therapy in the Treatment of Peri-Implantitis: A Randomized Controlled Split-Mouth Clinical Trial","PERISTER","Inclusion Criteria:\n\n* Patients aged between 18 and 70 years\n* Presence of peri-implantitis involving at least two dental implants located in different quadrants\n* Presence of bleeding and\u002For suppuration on probing\n* Increased probing depth (PD) and radiographic bone loss compared to previous examinations\n* In the absence of previous clinical data: PD ≥ 6 mm and bone loss ≥ 3 mm apically from the coronal portion of the intraosseous implant area (radiographically assessed)\n* Willingness and ability to comply with study protocol and follow-up visits\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Patients with cardiac pacemakers or other implanted electronic devices\n* Neurological or psychiatric disorders that may interfere with study participation\n* Systemic diseases, metabolic disorders, or autoimmune conditions\n* Pregnancy or lactation Current participation in other clinical trials","ALL","18 Years","70 Years",{"count":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study is a randomized controlled clinical trial using a split-mouth design to evaluate the effectiveness of a natural bioactive gel (Sterify Gel®) as an adjunct to standard non-surgical therapy for peri-implantitis. Peri-implantitis is an inflammatory disease that affects the tissues around dental implants and can lead to bone loss and implant failure. The goal of the study is to determine whether the application of Sterify Gel®, which contains polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, can improve clinical outcomes when used in addition to conventional mechanical debridement and air-polishing.\n\nThe trial will include 20 patients, each with at least two implants in different quadrants affected by peri-implantitis. One implant will be treated with standard therapy plus the gel (test site), while the other will receive standard therapy alone (control site). Clinical outcomes will be measured over a 9-month period, including plaque levels, bleeding on probing, probing depth, suppuration, and bone loss. The results will help assess whether this gel enhances the effectiveness of routine non-surgical peri-implantitis treatment.",[80,81,82],"Peri-implantitis","Dental Implants","Non-surgical Periodontal Therapy",[80,84,85,86,87,88,89,90,91],"Dental implants","Bioactive gel","Sterify Gel","Non-surgical therapy","Split-mouth design","Oral biofilm","Mechanical debridement","Randomized controlled trial","2025-08-17",{"date":94,"type":95},"2025-08-22","ACTUAL",{"date":97,"type":95},"2025-07-30",{"date":99,"type":74},"2026-05-30",{"name":5,"class":6},1]