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

Study acronym: HA35-PERI
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Study title shortened, about 4 wordsv2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07577258
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)		 Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain, Gingival Redness and Swelling, Gingival Bleeding
Related terms Gingival Hemorrhage, Gingival Recession, Periodontal Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov