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Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation
Sponsor: Nakhia Impex LLC
Summary
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.
Official title: A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Mild Gingival Recession and Chronic Periodontal Inflammation
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-06-01
Completion Date
2026-08-01
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel
Topical 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.