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

A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Post-Dental Gingival Pain and Swelling

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Inflammation; Post-Dental Gingival Pain; Gingival Swelling; Postoperative Oral Pain; Dental Procedure-Related Discomfort
• Intervention / Treatment: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years, male or female
• Experienced gingival pain and swelling within 12 hours after dental procedures
• Baseline gingival pain NRS score ≥2
• Able to independently complete pain and swelling assessments
• Signed written informed consent

Exclusion Criteria:

• Severe periodontitis, uncontrolled diabetes, or immune dysfunction
• Long-term use of analgesics or anti-inflammatory drugs
• Known hypersensitivity to hyaluronan or gel components
• Oral infection, ulceration, or severe mucosal injury at the application site
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HA35 Gel Topical Application Group; 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.; Other Names: HA35 Dental Gel; Gingival Care HA35 Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 1, 30, and 60 minutes after application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Throughout the 60-minute observation period

Collaborators and Investigators

• Sponsor: Nakhia Impex LLC

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Analgesia; Hyaluronan; HA35; Pilot Clinical Study; 35 kDa Hyaluronan; Topical Gel; Gingival Pain; Gingival Swelling; Dental Postoperative Care; Anti-Inflammation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: HA35202606

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No