[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639272":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":24,"collaborators":23,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":32,"eligibilityCriteria":33,"healthyVolunteers":28,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":23,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":50,"overallStatus":59,"whyStopped":23,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":23},{"fullName":5,"class":6},"Nakhia Impex LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HA35 Gel Topical Application Group","EXPERIMENTAL","Participants receive 10% high-concentration 35 kDa HA35 gel delivered via gel-soaked cotton balls, which are gently chewed and held in the affected gingival area for 30 minutes to allow sustained local infiltration. Efficacy on gingival pain, swelling, and safety will be evaluated.",[13],"Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel","Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment. Delivered via gel-soaked cotton balls that are gently chewed and retained in the mouth for sustained infiltration into the affected gingival area to relieve post-dental pain and reduce swelling.",[9],[21,22],"HA35 Dental Gel","Gingival Care HA35 Gel",null,{"type":25,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100639272","efficacy-and-safety-of-ha35-gel-for-post-dental-gingival-pain-and-swelling-100639272",false,"NCT07584655","Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling","A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Post-Dental Gingival Pain and Swelling","HA35","Inclusion Criteria:\n\n* Age 18-65 years, male or female\n* Experienced gingival pain and swelling within 12 hours after dental procedures\n* Baseline gingival pain NRS score ≥2\n* Able to independently complete pain and swelling assessments\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Severe periodontitis, uncontrolled diabetes, or immune dysfunction\n* Long-term use of analgesics or anti-inflammatory drugs\n* Known hypersensitivity to hyaluronan or gel components\n* Oral infection, ulceration, or severe mucosal injury at the application site\n* Pregnant or lactating women","ALL","18 Years","65 Years",{"count":38,"type":39},30,"ESTIMATED","INTERVENTIONAL",[42],"NA","This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls in patients with gingival pain and swelling after dental procedures. Eligible participants will gently chew and retain the gel-soaked cotton balls on the affected area for 30 minutes. The primary objectives are to assess changes in gingival pain and swelling at 1, 30, and 60 minutes after application. Safety and local oral tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.",[45,46,47,48,49],"Post-Dental Gingival Pain","Gingival Swelling","Postoperative Oral Pain","Dental Procedure-Related Discomfort","Periodontal Inflammation",[51,52,32,53,54,46,55,56,57,58],"Hyaluronan","35 kDa Hyaluronan","Topical Gel","Gingival Pain","Dental Postoperative Care","Analgesia","Anti-Inflammation","Pilot Clinical Study","NOT_YET_RECRUITING","2026-05-07",{"date":62,"type":63},"2026-05-13","ACTUAL",{"date":65,"type":39},"2026-06-01",{"date":67,"type":39},"2026-08-01",{"name":5,"class":6}]