[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509923":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":78,"collaborators":49,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":49,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":49,"enrollmentInfo":91,"targetDuration":49,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":49,"overallStatus":58,"whyStopped":49,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Marquette University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Ibuprofen group or Test Group","EXPERIMENTAL","Subjects will be given ibuprofen 600mg tab 1h prior to surgery.",[13,14],"Drug: Ibuprofen 600 mg","Drug: Acetaminophen",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo group or Control group","PLACEBO_COMPARATOR","Subjects will be given a placebo tab 1h prior to surgery.",[20,14],"Drug: Placebo",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Ibuprofen 600 mg","Preoperative delivery of ibuprofen per os.",[9],[28],"Test",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Preoperative delivery of placebo per os.",[16],[34],"Control",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Acetaminophen","Both groups will be given rescue medication in the form of 1,000 mg tabs of acetaminophen every 6 hours per os as needed for pain (maximum allowed daily dose 4,000 mg per FDA) and will be allowed to receive ibuprofen or other analgesic medication as needed if pain is not controlled by acetaminophen alone. The subjects will receive the rescue medication pills at the end of the surgical appointment.",[9,16],[40],"Rescue medication",[42],{"name":43,"affiliation":5,"role":44},"Vrisiis Kofina, DDS, MS","PRINCIPAL_INVESTIGATOR",[46,51],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","516-817-0393",null,"vrisiis.kofina@marquette.edu",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Christos Gousias, DDS","414-229-8875","christos.gousias@marquette.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Marquette University School of Dentistry Graduate Periodontics Clinic","RECRUITING","Milwaukee","Wisconsin","53233","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-87.90647,43.0389,{"lat":68,"lon":67},[71,73,77],{"name":43,"role":47,"phone":72,"phoneExt":49,"email":50},"4142886521",{"name":74,"role":47,"phone":75,"phoneExt":49,"email":76},"Arndt Guentsch, DMD, PhD, MHBA, MS","4142886089","arndt.guentsch@marquette.edu",{"name":43,"role":44,"phone":49,"phoneExt":49,"email":49},{"type":44,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Vrisiis Kofina","Director, Advanced Education in Periodontics Program, Assistant Professor of Periodontics","100509923","phase-4-preemptive-ibuprofen-effects-on-pain-perception-following-extraction-and-bone-graft-100509923",false,"NCT05919745","Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft","Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical Trial","Inclusion Criteria\n\n* Age \\>18 years\n* Good general health (controlled conditions)\n* Fluent in English\n* Treatment-planned for single site extraction and bone graft surgery\n\nExclusion criteria\n\n* Pregnancy\n* Site with active infection i.e purulence, abscess formation\n* Patients experiencing pain pre-operatively\n* Oral surgery in more than one site\u002Fquadrant in the same session\n* Patients receiving surgery under sedation\n* Patients with any contraindication for oral bone grafting surgery (e.g., on anticoagulants, medication-related osteonecrosis of the jaw, etc.)\n* Patients experiencing acute or chronic oral pain due to conditions or previous interventions\n* Patients with diseases or taking medications that affect hard and soft tissue wound healing such as poorly controlled diabetes, bisphosphonate use, corticosteroid use, chemotherapy, immunosuppressive therapy, etc.\n* Current or chronic (≥4 weeks) use of anti-inflammatory, analgesic, corticosteroid or sedative medications in the past 6 months\n* Health conditions that contraindicate the use of NSAIDs, such as stomach ulcers, bleeding disorders, renal disfunction, liver cirrhosis or acute liver disease, etc.\n* Intake of medications that interact with NSAIDs or whose actions can be affected by NSAIDs, such as anticoagulant\u002Fantiplatelet medications, ACE inhibitors, diuretics, etc.\n* Allergy to ibuprofen, acetaminophen and\u002For aspirin, and study materials (e.g., sutures, grafts, membranes?).\n* Patients having 3 or more alcoholic beverages daily\n* Patients who are planned to undergo heart surgery or had heart surgery less than 6 months prior\n* Not fluent in English",true,"ALL","18 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","The goal of this randomized clinical trial is to compare patient-reported pain and oral health-related quality of life during the first postoperative week following extraction and bone graft surgery in patients who received preemptive ibuprofen versus placebo. Participants will receive ibuprofen 600mg or placebo by mouth with water 1 hour prior to extraction and bone graft surgery.\n\nThe primary question it aims to answer is:\n\n• Does preemptive ibuprofen have an effect on postoperative pain 1 hour following extraction and bone graft surgery compared to placebo?\n\nSecondary questions are:\n\n* Does preemptive ibuprofen have an effect on pain during the first 3 postoperative hours and 7 postoperative days following extraction and bone graft surgery compared to placebo?\n* Does preemptive ibuprofen have an effect on oral health-related quality of life during the 7 postoperative days following extraction and bone graft surgery compared to placebo?",[99,100],"Pain, Post Operative","Quality of Life","2024-09-25",{"date":103,"type":104},"2024-09-27","ACTUAL",{"date":106,"type":104},"2023-10-19",{"date":108,"type":93},"2026-12",{"name":5,"class":6},1]