Menu
Not yet recruiting NCT07577258

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

No phase Interventional Mild Gingival Recession Periodontal Inflammation Chronic Gingival Pain Gingival Redness and Swelling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel.
Who it may be relevant to
Registry conditions: Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain, Gingival Redness and Swelling. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Change in Gingival Recession Depth (mm) [Time frame: Baseline to Day 42]
Secondary outcome measures (5)
  • Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS) [Time frame: 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 Redness and Swelling Severity (0-10 Scale) [Time frame: Baseline to Day 4]
  • Resolution Rate of Brushing-Induced Gingival Bleeding [Time frame: Baseline to Day 2]
  • Incidence and Severity of Oral Adverse Events [Time frame: Throughout the 42-day treatment period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07577258 · HA35202607

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗