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

This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic and anti-inflammatory efficacy of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls for managing gingival pain and swelling following dental procedures (including restoration, transplantation, extraction, and scaling).

Eligible subjects will place HA35 gel-soaked sterile cotton balls on the affected gingival area, gently chew and retain the cotton balls in place for 30 minutes to allow sustained local infiltration. Pain intensity will be assessed using a 0-10 Numeric Rating Scale (NRS), and gingival swelling using a 0-10 Visual Analog Scale (VAS) at baseline, 1 minute, 30 minutes, and 60 minutes after application.

Oral irritation, allergic reactions, and adverse events will be monitored for safety assessment.

This is a non-invasive, non-pharmacological oral topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.

Inclusion criteria

• 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
• Signed written informed consent

Exclusion criteria

• 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
• Pregnant or lactating women