Chronic Gingival Pain, Gingival Bleeding, Gingival Redness and Swelling, Mild Gingival Recession, Periodontal Inflammation
Conditions
Keywords
Hyaluronan, 35 kDa Hyaluronan, HA35, Gingival Recession, Periodontal Disease, Gingival Pain, Gingival Bleeding, Gingival Repair, Oral Care, Pilot Clinical Study
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.
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.
Interventions
DEVICE10% 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.
Sponsors
Nakhia Impex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Recession Depth (mm) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS) | 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. |
| Change in Gingival Itching/Discomfort Intensity (0-10 NRS) | 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. |
| Change in Gingival Redness and Swelling Severity (0-10 Scale) | 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. |
| Resolution Rate of Brushing-Induced Gingival Bleeding | Baseline to Day 2 | Proportion of participants with complete resolution of brushing-induced gingival bleeding, defined as no bleeding observed during gentle tooth brushing. |
| Incidence and Severity of Oral Adverse Events | 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). |
Outcome results
None listed