[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":31,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":31,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Azienda Ospedaliera di Perugia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyper-oxygenated Gel","ACTIVE_COMPARATOR","Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000mg x 2 times a day x 7 days) are prescribed.\n\nFurthermore, patients will have to use the Novox drop at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use).",[13],"Other: Hyper-oxygenated gel",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients undergoing lower third molar extraction. Post-operatively, the antibiotic (amoxicillin + clavulanic acid) and the painkiller (paracetamol 1000 mg x 2 times a day x 7 days) are prescribed.\n\nFurthermore, patients will have to use the Placebo, glycerin based gel, at the post-extraction site 3 times a day for 7 days (without taking liquids for 30 minutes after use).",[19],"Other: glycerin based gel",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Hyper-oxygenated gel","Novox drop is a medical device (CE certified, class II b, non-invasive) based on oxygen-enriched olive oil (Excipients: Mint essential oil (2%), Stevia extract (1%)). Mechanism of action: facilitate the healing process by creating, thanks to the release of reactive oxygen species (ROS), a microenvironment favorable to the activation of the microcirculation and at the same time unfavorable to the proliferation of pathogens. Furthermore, it has a film-forming, protective, barrier and soothing action thanks to its oily nature.",[9],[26],"Novox drop",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"glycerin based gel","The placebo consists of a viscous, colorless and transparent gel, based on glycerin (Conformity:FUI).",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Massimiliano Gilli, Dr","Azienda Ospedaliera Perugia","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"valeria mitro, Dr","CONTACT","+393494509722","valeria.mitro@ospedale.perugia.it",{"name":34,"role":40,"phone":44,"phoneExt":31,"email":45},"+393200360473","massimiliano.gilli@ospedale.perugia.it",[47],{"facility":48,"status":49,"city":50,"state":31,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Ospedale Santa Maria della Misericordia","RECRUITING","Perugia","06156","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],12.38878,43.1122,{"lat":58,"lon":57},[61,63],{"name":62,"role":40,"phone":41,"phoneExt":31,"email":42},"valeria mitro, dr",{"name":64,"role":40,"phone":44,"phoneExt":31,"email":45},"massimiliano gilli, dr",{"type":36,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Mitro Valeria","Principal Investigator","100551314","effects-of-the-application-of-a-hyper-oxygenated-gel-after-oral-surgery-100551314",false,"NCT06458478","Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery","Effects of the Application of a Hyper-oxygenated Gel After Extraction of Impacted Lower Third Molars: Randomized Controlled Study","Inclusion Criteria:\n\n* good systemic and local health conditions of the patient;\n* age between 18 and 35 years;\n* understanding of the Italian language,\n* indications for the extraction of impacted bilateral lower third molars (38 and 48) according to the criteria reported in the classifications of Winter and that of Pell and Gregory;\n* the root of the impacted third molars is completely formed.\n\nExclusion Criteria:\n\n* diabetes mellitus;\n* systemic arterial hypertension;\n* hyperthyroidism;\n* osteoporosis;\n* immunosuppressed;\n* osteonecrosis of the jaws;\n* pregnancy;\n* patients with mandibular third molars in position C according to \"the Pell \\& Gregory Classification\" on the radiological measurements (angles and positions) for which third molar extraction surgery is required.;\n* local alterations such as pericoronitis, odontogenic cysts and tumors in relation to the third molars;\n* allergies;\n* ordinary use of analgesics or antibiotics by the patient.","ALL","18 Years","35 Years",{"count":79,"type":80},72,"ESTIMATED","INTERVENTIONAL",[83],"NA","The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage.\n\nThe primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).",[86,87,88,89,90],"Molar, Fourth","Extracting Own Teeth","Edema Face","Pain","Trismus",[92,93,94,95,96,97],"dysodontiasis","third molar","oral surgery","edema","trismus","pain","2024-06-12",{"date":100,"type":101},"2024-06-13","ACTUAL",{"date":103,"type":80},"2024-07-01",{"date":105,"type":80},"2025-02-01",{"name":5,"class":6},1]