Clinical Trial

Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling

Study acronym: HA35
Not Yet Recruiting
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Record status
This record was last updated May 13, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07584655
Lead Sponsor Nakhia Impex LLC
Conditions Post-Dental Gingival Pain, Gingival Swelling, Postoperative Oral Pain, Dental Procedure-Related Discomfort, Periodontal Inflammation
Enrollment 30 participants
Start Date 2026-06-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-13