[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658705":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":26,"interventions":39,"overallOfficials":49,"centralContacts":54,"locations":60,"responsibleParty":76,"collaborators":17,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":17,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":17,"maxAge":17,"enrollmentInfo":87,"targetDuration":17,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":17,"overallStatus":63,"whyStopped":17,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Thamar University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Postoperative Pain Severit","Assessment of pain intensity using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).","8 hours, 3 days, and 7 days post-treatment.",{"measure":14,"description":15,"timeFrame":16},"Facial Edema","Assessment of facial swelling using the Ristow 5-line anatomic measurement method.","Baseline, 8 hours, 3 days, and 7 days post-treatment.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":24},"SINGLE",[25],"PARTICIPANT",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Pluronic Hydrogel Group","EXPERIMENTAL","Topical application of Pluronic F-127 hydrogel loaded with dexamethasone and diclofenac on facial soft tissue wounds.",[32],"Drug: Poloxmer F-127 Hydrogel with Dexamethasone\u002FDiclofenac",{"label":34,"type":35,"description":36,"interventionNames":37},"Placebo Control Group","ACTIVE_COMPARATOR","Topical application of plain Pluronic F-127 hydrogel base without active ingredients (dexamethasone or diclofenac).",[38],"Other: Plain Pluronic F-127 Hydrogel Placebo",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":17},"DRUG","Poloxmer F-127 Hydrogel with Dexamethasone\u002FDiclofenac","Active topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control.",[28],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"Plain Pluronic F-127 Hydrogel Placebo","Blank hydrogel vehicle without active pharmacologic agents.",[34],[50],{"name":51,"affiliation":52,"role":53},"Nashwan Hamid Al-Tairi, Associate Professor","Faculty of Dentistry, Thamar University","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":17,"email":59},"Arshad Mohammed Almansori, BDS","CONTACT","0771697007","arshadalmansori987@gmail.com",[61],{"facility":62,"status":63,"city":64,"state":17,"zip":17,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Alwehdah University Teaching Hospital","RECRUITING","Dhamar","Yemen","YE",{"type":68,"coordinates":69},"Point",[70,71],44.40514,14.54274,{"lat":71,"lon":70},[74],{"name":75,"role":57,"phone":58,"phoneExt":17,"email":59},"Arshad mohammed Almansori, MSc Candidate",{"type":53,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Arshad Mohammed Abdu abduallah Almansouri","MSc Candidate","100658705","phase-2-topical-dexamethasonediclofenac-hydrogel-for-postoperative-pain-and-swelling-in-facial-soft-tissue-injuries-100658705",false,"NCT07853664","Topical Dexamethasone\u002FDiclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries","Clinical Evaluation of a Topical Hydrogel Loaded With Dual Anti-Inflammatory Agents for Postoperative Pain and Swelling Control in Facial Soft Tissue Injuries","Inclusion and Exclusion Criteria Inclusion Criteria\n\n* Patients undergoing oral and maxillofacial fracture surgeries involving clean surgical incisions .\n* Patients presenting with clean oral and maxillofacial soft tissue injuries due to trauma, suitable for primary closure\n* ASA class I-II .\n* Willing to comply with postoperative follow-up and consent procedures .\n\nExclusion Criteria\n\n* Patients with infected, contaminated, or extensive avulsive wounds .\n* Wounds requiring secondary healing or grafting .\n* Patients with systemic conditions affecting healing (e.g., diabetes, immunosuppression) .\n* Patients with known allergy to DEX or DIC .\n* Pregnant or lactating females .\n* Patients with chronic steroid or NSAID use .\n* Active infections at the surgical site .","ALL",{"count":88,"type":89},52,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE2","PHASE3","This randomized, controlled clinical trial will evaluate the clinical effects of a topical thermoresponsive hydrogel containing dexamethasone sodium phosphate and diclofenac sodium on postoperative pain and facial swelling in patients undergoing extraoral maxillofacial surgical procedures or primary closure of clean facial soft tissue wounds. Participants will be stratified according to fracture status and randomly assigned to receive either the active hydrogel or an identical placebo hydrogel. Pain, facial swelling, wound healing, adverse events, patient satisfaction, and rescue analgesic consumption will be evaluated during the postoperative period.",[96,97,98],"Facial Injuries","Pain","Swelling","2026-09-26",{"date":101,"type":102},"2026-10-02","ACTUAL",{"date":104,"type":102},"2026-01-01",{"date":106,"type":89},"2027-01-01",{"name":5,"class":6},1]