An interventional study of 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel in Post-Dental Gingival Pain, Gingival Swelling and Postoperative Oral Pain, sponsored by Nakhia Impex LLC. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Supportive care
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.
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic and anti-inflammatory efficacy of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls for managing gingival pain and swelling following dental procedures (including restoration, transplantation, extraction, and scaling).
Eligible subjects will place HA35 gel-soaked sterile cotton balls on the affected gingival area, gently chew and retain the cotton balls in place for 30 minutes to allow sustained local infiltration. Pain intensity will be assessed using a 0-10 Numeric Rating Scale (NRS), and gingival swelling using a 0-10 Visual Analog Scale (VAS) at baseline, 1 minute, 30 minutes, and 60 minutes after application.
Oral irritation, allergic reactions, and adverse events will be monitored for safety assessment.
This is a non-invasive, non-pharmacological oral topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
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This study's enrollment of 30 is below the median of 78 across 1,026 interventional studies indexed under Agnosia.
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Exclusion Criteria:
Participants receive 10% high-concentration 35 kDa HA35 gel delivered via gel-soaked cotton balls, which are gently chewed and held in the affected gingival area for 30 minutes to allow sustained local infiltration. Efficacy on gingival pain, swelling, and safety will be evaluated.
Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel
Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment. Delivered via gel-soaked cotton balls that are gently chewed and retained in the mouth for sustained infiltration into the affected gingival area to relieve post-dental pain and reduce swelling.
Also known as: HA35 Dental Gel, Gingival Care HA35 Gel
Change in Gingival Pain NRS Score (0-10)
Change in post-dental gingival pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
Time frame: Baseline to 1, 30, and 60 minutes after application
Change in Gingival Swelling Severity (0-10 VAS Score)
Change in gingival swelling severity at the treatment site, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no swelling and 10 = maximum swelling.
Time frame: Baseline to 1, 30, and 60 minutes after application
Onset Time of Gingival Pain Relief
Time from application to the first reported reduction in gingival pain intensity of ≥2 points on a 0-10 Numeric Rating Scale (NRS).
Time frame: Within 60 minutes after application
Incidence and Severity of Oral Adverse Events
Number and severity of treatment-related oral adverse events (e.g., irritation, numbness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Throughout the 60-minute observation period
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Nakhia Impex LLC