Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation (HA35-PERI)

May 7, 2026 updated by: Nakhia Impex LLC

A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Mild Gingival Recession and Chronic Periodontal Inflammation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving mild gingival recession (Miller Class I/II) and chronic periodontal inflammatory symptoms including gingival pain, redness, swelling, and brushing-induced bleeding.

Eligible subjects will perform routine tooth brushing followed by gentle topical application of HA35 gel to the gingival margin, teeth, and affected gingival areas for approximately 3 minutes, twice daily (morning and evening) for 42 consecutive days.

Outcome assessments include measurement of exposed root surface length (gingival recession), chronic gingival/radicular pain (NRS 0-10), gingival itching/discomfort, redness and swelling scores, and incidence of brushing-induced bleeding at baseline, 30 seconds after first application, Day 2, Day 4, and Day 42.

Oral irritation, allergic reactions, and adverse events will be monitored continuously 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HA35 Topical Gingival Gel Group
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
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.
Other Names:
  • HA35 Periodontal Gel
  • Gingival Repair HA35 Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gingival Recession Depth (mm)
Time Frame: Baseline to Day 42
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)
Time Frame: Baseline to Day 42
Change in chronic gingival or radicular pain intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain.
Baseline to Day 42
Change in Gingival Itching/Discomfort Intensity (0-10 NRS)
Time Frame: Baseline to 30 seconds after first application
Change in gingival itching or discomfort intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort and 10 = maximum discomfort.
Baseline to 30 seconds after first application
Change in Gingival Redness and Swelling Severity (0-10 Scale)
Time Frame: Baseline to Day 4
Change in gingival redness and swelling severity, assessed using a 0-10 ordinal scale, where 0 = normal gingiva and 10 = severe redness and swelling.
Baseline to Day 4
Resolution Rate of Brushing-Induced Gingival Bleeding
Time Frame: Baseline to Day 2
Proportion of participants with complete resolution of brushing-induced gingival bleeding, defined as no bleeding observed during gentle tooth brushing.
Baseline to Day 2
Incidence and Severity of Oral Adverse Events
Time Frame: Throughout the 42-day treatment period
Number and severity of treatment-related oral adverse events, including irritation, ulceration, or allergic reactions, assessed by clinical observation and participant report. Severity graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Throughout the 42-day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nakhia Impex LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 29, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA35202607

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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