[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648421":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":25,"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":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Freiburger Medizintechnik GmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Mechanical Debridement (S3)","ACTIVE_COMPARATOR","Guideline-compliant standard therapy only, consisting of mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.",[13],"Procedure: Standard Mechanical Debridement (S3 Guideline)",{"label":15,"type":16,"description":17,"interventionNames":18},"AmbiJet Cold Plasma + Standard Debridement","EXPERIMENTAL","Adjuvant application of cold atmospheric pressure plasma using the AmbiJet system directly onto the affected implant surfaces, performed immediately following standard mechanical debridement according to the S3 guideline.",[19,13],"Device: AmbiJet cold plasma system",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DEVICE","AmbiJet cold plasma system",[15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Standard Mechanical Debridement (S3 Guideline)","Mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.",[15,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Loic Ledernez, Phd","CONTACT","+49 176 96127565","ledernez@frmed.de",[38],{"facility":39,"status":40,"city":41,"state":25,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"LLC \"Institute of Implantological Research","RECRUITING","Romny","42001","Ukraine","UA",{"type":46,"coordinates":47},"Point",[48,49],33.4952,50.74025,{"lat":49,"lon":48},[52,56],{"name":53,"role":34,"phone":54,"phoneExt":25,"email":55},"Dmytro Kaplun, Phd","+38(066) 700-59-25","da8in4eg@gmail.com",{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"Kaplun Kaplun, Phd","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100648421","study-on-the-treatment-of-dental-implants-using-the-ambijet-system-for-peri-implantitis-and-peri-implant-mucositis-100648421",false,"NCT07722715","Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis","Randomized, Controlled, Exploratory Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis (AmbiJet-FIH)","AmbiJet-FIH","Inclusion Criteria:\n\nGeneral criteria:\n\n* Men or women aged \\>= 18 and \\\u003C= 65 years.\n* For women of childbearing age: a form of contraception recognized by conventional medicine during the study.\n* Written consent has been obtained from each patient for the study.\n\nDental criteria:\n\n* Current X-ray of the implant region available (\\\u003C= 6 months prior to first treatment).\n* One to five implants with bone loss from the start of the part of the implant intended for osseointegration (X-ray findings).\n* Bleeding and\u002For suppuration after or without probing at the implant in question (peri-implant mucositis\u002Fperi-implantitis).\n* Clinical signs of inflammation (swelling, redness, soft tissue) on the implant in question (peri-implant mucositis\u002Fperi-implantitis).\n* Average oral hygiene (i.e., brushing teeth at least twice a day).\n\nExclusion Criteria:\n\nGeneral criteria:\n\n* Known allergies to materials used in the study (gold, copper, polyimide).\n* Diabetes (type I or type II), vasculitis, osteoporosis, osteomalacia.\n* Smokers (\\>1 cigarette\u002Fweek).\n* Use of medications to modulate bone metabolism (e.g., bisphosphonates).\n* Eating disorders such as bulimia or anorexia nervosa.\n* Use of antibiotics within the last 2 months prior to the start of the study.\n* Application of local antibiotics in the oral cavity within the last 2 months prior to the start of the study.\n* Use of antimicrobial mouthwashes within the last month before the start of the study.\n* Anti-inflammatory medication within the last month before the start of the study.\n* Pregnancy or breastfeeding.\n* Alcoholism or drug abuse.\n* Wound healing disorders.\n* Immunosuppression.\n* Condition following insertion of an electrical, electrically active, or electronic implant.\n\nDental criteria:\n\n* An implant with bone loss \\>6 mm from the start of the part of the implant intended for osseointegration (X-ray findings) (peri-implantitis).\n* Pathological changes in the oral mucosa or gingiva, such as oral lichen planus, chronic recurrent aphthae, melanotic macula, precancerous lesions (e.g., leukoplakia), melanomas.\n* Use of medically unacceptable types of treatment, therapies, or substances (off-label use of treatments for peri-implant mucositis or peri-implantitis).","ALL","18 Years","65 Years",{"count":73,"type":74},26,"ESTIMATED","INTERVENTIONAL",[77],"NA","Inflammation of the tissue surrounding a dental implant (peri-implantitis or peri-implant mucositis) can lead to implant loss in advanced stages. The AmbiJet system utilizes cold atmospheric plasma (CAP), a physical procedure with a strong antibacterial effect. This clinical trial investigates whether the additional application of cold plasma directly on the patient following conventional mechanical cleaning of the implants is safe, well-tolerated, and resolves inflammation more quickly compared to standard treatment.",[80,81],"Peri Implant Mucositis","Peri Implantitis",[83,84,85],"Plasma Medicine","Cold Atmospheric Plasma","AmbiJet","2026-07-23",{"date":88,"type":89},"2026-07-24","ACTUAL",{"date":91,"type":89},"2026-02-14",{"date":93,"type":74},"2026-11-20",{"name":5,"class":6},1]