An interventional study of 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel in Mild Gingival Recession, Periodontal Inflammation and Chronic Gingival Pain, sponsored by Nakhia Impex LLC. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
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 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.
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.
53 studies on the registry are indexed under Gingival Hemorrhage; 16 are open to participants now.
This study's enrollment of 30 is below the median of 54 across 49 interventional studies indexed under Gingival Hemorrhage.
Browse Gingival Hemorrhage studies →Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: HA35 Periodontal Gel, Gingival Repair HA35 Gel
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.
Time frame: Baseline to Day 42
Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)
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.
Time frame: Baseline to Day 42
Change in Gingival Itching/Discomfort Intensity (0-10 NRS)
Change in gingival itching or discomfort intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort and 10 = maximum discomfort.
Time frame: Baseline to 30 seconds after first application
Change in Gingival Redness and Swelling Severity (0-10 Scale)
Change in gingival redness and swelling severity, assessed using a 0-10 ordinal scale, where 0 = normal gingiva and 10 = severe redness and swelling.
Time frame: Baseline to Day 4
Resolution Rate of Brushing-Induced Gingival Bleeding
Proportion of participants with complete resolution of brushing-induced gingival bleeding, defined as no bleeding observed during gentle tooth brushing.
Time frame: Baseline to Day 2
Incidence and Severity of Oral Adverse Events
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).
Time frame: Throughout the 42-day treatment 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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