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
Single group
10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel
DeviceTopical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied topically to gingival and tooth surfaces to improve mild gingival recession, reduce periodontal inflammation, relieve gingival pain, and decrease brushing-induced bleeding.
Change in Gingival Recession Depth (mm)
Change in gingival recession depth, measured in millimeters (mm) using a calibrated periodontal probe. Baseline measurement is the distance from the cementoenamel junction (CEJ) to the gingival margin.
Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)
Change in chronic gingival or radicular pain intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain.
Change in Gingival Itching/Discomfort Intensity (0-10 NRS)
Change in gingival itching or discomfort intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort and 10 = maximum discomfort.
Change in Gingival Redness and Swelling Severity (0-10 Scale)
Change in gingival redness and swelling severity, assessed using a 0-10 ordinal scale, where 0 = normal gingiva and 10 = severe redness and swelling.
Resolution Rate of Brushing-Induced Gingival Bleeding
Proportion of participants with complete resolution of brushing-induced gingival bleeding, defined as no bleeding observed during gentle tooth brushing.
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