Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation
CompletedNot applicableNCT07577258
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Mild Gingival Recession
- Periodontal Inflammation
- Chronic Gingival Pain
- Gingival Redness and Swelling
- Gingival Bleeding
- Interventions
- Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel
- Sponsor
- Nakhia Impex LLC
- Start date
- 2026-06-01
- Primary completion
- 2026-07-01
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07577258