This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with mild gingival recession and chronic periodontal inflammation. Eligible participants will apply the HA35 gel topically to the gingival and tooth surfaces twice daily for 42 consecutive days. The primary objectives are to assess changes in gingival recession, chronic gingival or radicular pain, gingival redness and swelling, and brushing-induced bleeding. Safety and local oral tolerability will be evaluated throughout the treatment period. This is a minimal-risk, non-pharmacological, non-invasive oral care intervention.
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
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