[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633650":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":47,"locations":53,"responsibleParty":71,"collaborators":32,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":32,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":32,"maxAge":32,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":56,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Zagreb","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Laser PDT + Saline Rinse","EXPERIMENTAL","Implants in this group will undergo surface decontamination using Photodynamic Therapy (PDT). This involves the application of a riboflavin photosensitizer activated by a blue laser, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.\n\nInterventions:\n\nDevice \u002F Procedure: Laser Photodynamic Therapy (PDT)\n\nProcedure: Guided Bone Regeneration (GBR)",[13,14],"Device: Laser Photodynamic Therapy (PDT)","Procedure: Guided Bone Regeneration (GBR)",{"label":16,"type":10,"description":17,"interventionNames":18},"GalvoSurge + Saline Rinse","Implants in this group will undergo surface decontamination using the GalvoSurge electrolytic cleaning system, followed by a rinse with sterile normal saline solution. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.\n\nInterventions:\n\nDevice \u002F Procedure: GalvoSurge Electrolytic Cleaning\n\nProcedure: Guided Bone Regeneration (GBR)",[19,14],"Device: GalvoSurge Electrolytic Cleaning",{"label":21,"type":22,"description":23,"interventionNames":24},"Chlorhexidine Rinse (Control)","ACTIVE_COMPARATOR","Implants in this control group will undergo surface decontamination using the current clinical gold standard, which is a 0.2% chlorhexidine gluconate rinse. The decontamination is performed immediately after the baseline microbiological swab (Sample 1) and before the post-treatment swab (Sample 2). All implants will subsequently receive a standard Guided Bone Regeneration (GBR) procedure.\n\nInterventions:\n\nDrug \u002F Procedure: 0.2% Chlorhexidine Gluconate Rinse\n\nProcedure: Guided Bone Regeneration (GBR)",[25,14],"Drug: 0.2% Chlorhexidine Gluconate",[27,33,37,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Laser Photodynamic Therapy (PDT)","Antimicrobial photodynamic therapy applied to the contaminated implant surface. This involves the application of a riboflavin photosensitizer which is then activated by a blue laser to generate reactive oxygen species and eliminate bacterial biofilm. The procedure is concluded with a sterile normal saline rinse.\n\nArm Group(s): Laser PDT + Saline Rinse",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"GalvoSurge Electrolytic Cleaning","Decontamination of the implant surface using the GalvoSurge dental device. This system utilizes an electrolytic process with a specific cleaning solution to actively lift and detach the bacterial biofilm from the rough titanium surface. The procedure is concluded with a sterile normal saline rinse.\n\nArm Group(s): GalvoSurge + Saline Rinse",[16],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"DRUG","0.2% Chlorhexidine Gluconate","Chemical decontamination of the implant surface by rinsing it thoroughly with a 0.2% chlorhexidine gluconate solution, which serves as the active control\u002Fgold standard for antimicrobial reduction.\n\nArm Group(s): Chlorhexidine Rinse (Control)",[21],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":32},"PROCEDURE","Guided Bone Regeneration (GBR)","A classic surgical bone grafting procedure performed on all implants immediately following their assigned decontamination protocol. The procedure involves placing a mixture of autologous bone particles and a xenograft around the implant, which is then covered by a collagen membrane fixed in place using titanium pins.\n\nArm Group(s): Laser PDT + Saline Rinse; GalvoSurge + Saline Rinse; Chlorhexidine Rinse (Control)",[21,16,9],[48],{"name":49,"role":50,"phone":51,"phoneExt":32,"email":52},"Igor Smojver, DMD;PhD","CONTACT","385981651932","ismojver@sfzg.hr",[54],{"facility":55,"status":56,"city":57,"state":32,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"School of Dental Medicine","RECRUITING","Zagreb","10000","Croatia","HR",{"type":62,"coordinates":63},"Point",[64,65],15.97798,45.81444,{"lat":65,"lon":64},[68],{"name":69,"role":50,"phone":70,"phoneExt":32,"email":52},"Igor Smojver, DMD,PhD","+385981651932",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Igor Smojver","Sinior assistant","100633650","microbiological-evaluation-of-the-effectiveness-of-different-surface-decontamination-protocols-for-dental-implants-100633650",false,"NCT07529444","Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants","Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants Using the Polymerase Chain Reaction Method","Inclusion Criteria:\n\nPatients presenting with at least one bone-level dental implant affected by peri-implantitis.\n\nThe affected implant must be deemed viable with a perspective for preservation\u002Fretention in the dental arch.\n\nPatients must be non-smokers.\n\nPatients in good general health, classified as ASA I (a normal healthy patient) or ASA II (a patient with mild systemic disease) according to the American Society of Anesthesiologists physical status classification system.\n\nExclusion Criteria:\n\nPresence of vertical bone loss around the affected implant.\n\nImplants that are not bone-level (e.g., tissue-level implants).\n\nPatients with any systemic comorbidities.\n\nPatients who are currently smokers.\n\nImplants with a poor prognosis that cannot be preserved in the dental arch.","ALL",{"count":84,"type":85},90,"ESTIMATED","INTERVENTIONAL",[88],"NA","The purpose of this prospective clinical study is to evaluate and compare the effectiveness of different cleaning (decontamination) methods for dental implants affected by peri-implantitis. Peri-implantitis is an inflammatory condition caused by a bacterial biofilm on the implant surface, which can lead to bone loss and implant failure if left untreated. Because the rough surface and threads of implants make them difficult to clean, finding the most effective decontamination method is critical for saving the implant.\n\nThis study will include 90 healthy, non-smoking participants who have a bone-level dental implant affected by peri-implantitis without vertical bone loss. Participants will be randomly assigned to one of three treatment groups (30 implants per group) to undergo a specific decontamination procedure during their surgical treatment:\n\nGroup 1 (Laser PDT): Decontamination using photodynamic therapy with a blue laser and riboflavin, followed by a sterile saline rinse.\n\nGroup 2 (GalvoSurge): Decontamination using an electrolytic cleaning device, followed by a sterile saline rinse.\n\nGroup 3 (Active Control): Decontamination using a 0.2% chlorhexidine gluconate rinse, which is the current standard of care.\n\nTo measure the effectiveness of these treatments, researchers will take sterile swabs from the implant surface immediately before and after the decontamination process. These swabs will be analyzed using PCR to detect changes in the microbiological load of five specific bacteria known to cause gum and implant disease (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythia).\n\nFollowing the decontamination and swabbing, all participants will receive a standard Guided Bone Regeneration (GBR) procedure using autogenous bone, a xenograft, and a collagen membrane to help rebuild the bone around the implant.\n\nBy comparing the microbiological results before and after treatment, the study aims to determine whether the newer methods (Laser PDT or electrolytic cleaning) are more effective at removing harmful bacteria than the traditional chlorhexidine rinse prior to bone regeneration.",[91,92,93],"Periimplant Diseases","Dental Implant Failure","Dental Implant Complications",[95,96,97,98,99,100],"peri-implantitis","implant decontamination","PDT","electrolytic cleaning","GalvoSurge","Chlorhexidine Gluconate","2026-04-07",{"date":103,"type":104},"2026-04-14","ACTUAL",{"date":106,"type":104},"2026-03-01",{"date":108,"type":85},"2027-06-01",{"name":5,"class":6},1]