Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation

This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving mild gingival recession (Miller Class I/II) and chronic periodontal inflammatory symptoms including gingival pain, redness, swelling, and brushing-induced bleeding.

Eligible subjects will perform routine tooth brushing followed by gentle topical application of HA35 gel to the gingival margin, teeth, and affected gingival areas for approximately 3 minutes, twice daily (morning and evening) for 42 consecutive days.

Outcome assessments include measurement of exposed root surface length (gingival recession), chronic gingival/radicular pain (NRS 0-10), gingival itching/discomfort, redness and swelling scores, and incidence of brushing-induced bleeding at baseline, 30 seconds after first application, Day 2, Day 4, and Day 42.

Oral irritation, allergic reactions, and adverse events will be monitored continuously 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 18-60 years, male or female
• Clinically diagnosed with mild gingival recession (Miller Class I or II)
• Chronic gingival pain, redness, swelling, or brushing-induced bleeding
• Ability to complete self-assessments and comply with 42-day intervention
• Signed written informed consent

Exclusion criteria

• Severe periodontitis, tooth mobility, or alveolar bone loss
• Uncontrolled diabetes or immune dysfunction
• Use of prescription periodontal medications within 2 weeks
• Known hypersensitivity to hyaluronan or gel components
• Oral infection, ulceration, or severe mucosal injury
• Pregnant or lactating women