Clinical Trial

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

Study acronym: HA35-PERI
Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated May 12, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-05.
Trial Details
NCT Number NCT07577258
Lead Sponsor Nakhia Impex LLC
Conditions Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain, Gingival Redness and Swelling, Gingival Bleeding
Enrollment 30 participants
Start Date 2026-06-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-12