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.
Age 18-65 years, male or female
Experienced gingival pain and swelling within 12 hours after dental procedures
Baseline gingival pain NRS score ≥2
Able to independently complete pain and swelling assessments
Severe periodontitis, uncontrolled diabetes, or immune dysfunction
Long-term use of analgesics or anti-inflammatory drugs
Known hypersensitivity to hyaluronan or gel components
Oral infection, ulceration, or severe mucosal injury at the application site
Single group
10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel
DeviceTopical 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.
Change in Gingival Pain NRS Score (0-10)
Change in post-dental gingival pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
Change in Gingival Swelling Severity (0-10 VAS Score)
Change in gingival swelling severity at the treatment site, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no swelling and 10 = maximum swelling.
Onset Time of Gingival Pain Relief
Time from application to the first reported reduction in gingival pain intensity of ≥2 points on a 0-10 Numeric Rating Scale (NRS).
Incidence and Severity of Oral Adverse Events
Number and severity of treatment-related oral adverse events (e.g., irritation, numbness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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