[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586372":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":70,"collaborators":25,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":25,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":25,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Universitat Internacional de Catalunya","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"non-surgical therapy","ACTIVE_COMPARATOR","Standardized peri-implant non-surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7\u002F89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing)",[13],"Procedure: Non-Surgical Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Test group: adjunctive PN-HA gel","EXPERIMENTAL","Standardized peri-implant non.surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7\u002F89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing). At the end of the peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg\u002Fml, 1%) and HA with molecular weight \\> 1500 kDa (10 mg\u002Fml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.",[19,13],"Other: viscoelastic gel containing a fixed combination of natural origin PN (10 mg\u002Fml, 1%) and HA with molecular weight > 1500 kDa (10 mg\u002Fml, 1%)",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"viscoelastic gel containing a fixed combination of natural origin PN (10 mg\u002Fml, 1%) and HA with molecular weight > 1500 kDa (10 mg\u002Fml, 1%)","At the end of the standardized peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg\u002Fml, 1%) and HA with molecular weight \\> 1500 kDa (10 mg\u002Fml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.",[15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Non-Surgical Intervention","Standardized peri-implant non-surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7\u002F89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing",[15,9],[32],{"name":33,"affiliation":34,"role":35},"Cristina Valles, Dentistry","Department of Periodontology, Universitat Internacional de Catalunya","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"MARIA C SOLDINI, dentistry","CONTACT","+393491302895","MARIACOSTANZA.SOLDIN@UIC.ES",[43,56],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":25},"Clinica Universitaria ́̀ d'Odontologia - UIC Barcelona at the Periodontology Department","Sant Cugat del Vallès","Barcelona","08195","Spain","ES",{"type":51,"coordinates":52},"Point",[53,54],2.08611,41.47063,{"lat":54,"lon":53},{"facility":47,"status":25,"city":45,"state":57,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Bracelona",{"type":51,"coordinates":59},[53,54],{"lat":54,"lon":53},[62,66,69],{"name":63,"role":39,"phone":64,"phoneExt":25,"email":65},"Maria I Alegra, Dentistry","+306947598127","mujalegra@gmail.com",{"name":67,"role":39,"phone":68,"phoneExt":25,"email":25},"Ramon Pons, Dentistry","+34619688364",{"name":33,"role":35,"phone":25,"phoneExt":25,"email":25},{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100586372","polynucleotide-and-hyaluronic-acid-based-gel-as-adjunctive-therapy-to-non--surgical-treatment-of-intraosseous-peri-implant-defect-a-randomized-clinical-trial-100586372",false,"NCT06914518","Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A Randomized Clinical Trial","Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A 6-month Randomized Clinical Trial","Inclusion Criteria:\n\nSubjects with (I) ≥ 18 years of age, the presence of at least one implant diagnosed with peri-implantitis, intraosseous ≥ 3mm defects, presence of screw-retained single-unit crowns and partial dental prosthesis that allowed correct access for brushing; and, if not, prostheses that could be modified.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they had received previous non-surgical peri-implantitis treatment during the last 6 months or surgical treatment, were pregnant or breast-feeding, had received antibiotic treatment in the previous 3 months, had systemic conditions that contraindicated treatment, smoking more than 10 cigarettes\u002Fday or presents a poor plaque control (Plaque Index \\\u003C 20%), implant mobility.","ALL","18 Years",{"count":82,"type":83},32,"ESTIMATED","INTERVENTIONAL",[86],"NA","This randomized, placebo-controlled clinical trial evaluates the efficacy of a polynucleotide and hyaluronic acid-based gel (PN-HA) as adjunctive therapy to non-surgical flapless treatment of peri-implantitis. The main goal is to assess probing pocket depth (PPD) reduction after 6 months compared to placebo.\n\nStudy Design:\n\n* Type: Interventional (Clinical Trial)\n* Allocation: Randomized (computer-generated blocks)\n* Intervention Model: Parallel assignment\n* Masking: Single-blind (examiner-blinded)\n* Primary Purpose: Treatment\n* Estimated Enrollment: 32 participants\n* Duration: 6 month follow-up",[89],"Peri-implantitis",[91,92,93,94],"peri-implantitis","non-surgical treatment","non-surgical treatment per-implantitis","hyaluronic acid","NOT_YET_RECRUITING","2025-09-17",{"date":98,"type":99},"2025-09-23","ACTUAL",{"date":101,"type":83},"2025-09-20",{"date":103,"type":83},"2026-06-01",{"name":5,"class":6},2]