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

NCT07584655 | Not Yet Recruiting

• 1 other identifier: HA35202606
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-Dental Gingival Pain; Gingival Swelling; Postoperative Oral Pain; Dental Procedure-Related Discomfort; Periodontal Inflammation

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Topical Gel; Gingival Pain; Gingival Swelling; Dental Postoperative Care; Analgesia; Anti-Inflammation; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Gingival Swelling Severity (0-10 VAS Score)

  Baseline to 1, 30, and 60 minutes after application

• Onset Time of Gingival Pain Relief

  Within 60 minutes after application

• Incidence and Severity of Oral Adverse Events

  Throughout the 60-minute observation period

Study Arms (1)

HA35 Gel Topical Application Group

EXPERIMENTAL

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

Interventions

10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel DEVICE

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

HA35 Gel Topical Application Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04