Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation
Starting soon · Not applicable
Conditions studied: Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain, Gingival Redness and Swelling, Gingival Bleeding
In brief
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.
Key facts
- Study ID
- NCT07577258
- Run by
- Nakhia Impex LLC
- People needed
- 30
- Starts
- 2026-06-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.