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

NCT07577258 | Not Yet Recruiting

• 1 other identifier: HA35202607
• 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 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.

Conditions

Mild Gingival Recession; Periodontal Inflammation; Chronic Gingival Pain; Gingival Redness and Swelling; Gingival Bleeding

Keywords

Hyaluronan; 35 kDa Hyaluronan; HA35; Gingival Recession; Periodontal Disease; Gingival Pain; Gingival Bleeding; Gingival Repair; Oral Care; Pilot Clinical Study

Outcome Measures

Primary Outcomes (1)

• Change in Gingival Recession Depth (mm)

  Change in gingival recession depth, measured in millimeters (mm) using a calibrated periodontal probe. Baseline measurement is the distance from the cementoenamel junction (CEJ) to the gingival margin.

  Baseline to Day 42

Secondary Outcomes (5)

• Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)

  Baseline to Day 42

• Change in Gingival Itching/Discomfort Intensity (0-10 NRS)

  Baseline to 30 seconds after first application

• Change in Gingival Redness and Swelling Severity (0-10 Scale)

  Baseline to Day 4

• Resolution Rate of Brushing-Induced Gingival Bleeding

  Baseline to Day 2

• Incidence and Severity of Oral Adverse Events

  Throughout the 42-day treatment period

Study Arms (1)

HA35 Topical Gingival Gel Group

EXPERIMENTAL

Participants apply 10% high-concentration 35 kDa HA35 gel topically to the gingival and tooth surfaces twice daily for 42 consecutive days. Efficacy on gingival recession, periodontal inflammation, pain, bleeding, and safety will be evaluated.

Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel

Interventions

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

Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment. Applied topically to gingival and tooth surfaces to improve mild gingival recession, reduce periodontal inflammation, relieve gingival pain, and decrease brushing-induced bleeding.

Also known as: HA35 Periodontal Gel, Gingival Repair HA35 Gel

HA35 Topical Gingival Gel Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years, male or female
• Clinically diagnosed with mild gingival recession (Miller Class I or II)
• Chronic gingival pain, redness, swelling, or brushing-induced bleeding
• Ability to complete self-assessments and comply with 42-day intervention
• Signed written informed consent

You may not qualify if:

• Severe periodontitis, tooth mobility, or alveolar bone loss
• Uncontrolled diabetes or immune dysfunction
• Use of prescription periodontal medications within 2 weeks
• Known hypersensitivity to hyaluronan or gel components
• Oral infection, ulceration, or severe mucosal injury
• Pregnant or lactating women

Sponsors & Collaborators

• Nakhia Impex LLC: lead

MeSH Terms

Conditions

Gingival Hemorrhage; Gingival Recession; Periodontal Diseases

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Atrophy

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 29, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-04