Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling

Study acronym: HA35
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 10 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. 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 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls in patients with gingival pain and swelling after dental procedures. Eligible participants will gently chew and retain the gel-soaked cotton balls on the affected area for 30 minutes. The primary objectives are to assess changes in gingival pain and swelling at 1, 30, and 60 minutes after application. Safety and local oral tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.
Trial Details
NCT Number NCT07584655
Lead Sponsor Nakhia Impex LLC
Conditions
(from sponsor)		 Post-Dental Gingival Pain, Gingival Swelling, Postoperative Oral Pain, Dental Procedure-Related Discomfort, Periodontal Inflammation
Related terms Agnosia
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov