Mild Gingival RecessionHA35-PERINCT07577258
Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel in people with Mild Gingival Recession and Periodontal Inflammation, run by Nakhia Impex LLC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain
- What is being tested?
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain, Gingival Redness and Swelling, Gingival Bleeding
- Being tested
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Gingival Recession, Periodontal Disease, Gingival Pain, Gingival Bleeding, Gingival Repair, Oral Care, Pilot Clinical Study
- Medical subject headings
- Gingival Hemorrhage, Gingival Recession, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical GelDevice
Also called HA35 Periodontal Gel, Gingival Repair HA35 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.
| Study group | Role | What they receive |
|---|---|---|
| HA35 Topical Gingival Gel Group | Experimental | 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. Receives: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 42
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Throughout the 42-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jun 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577258
- Sponsor's protocol ID
- HA35202607
- Acronym
- HA35-PERI
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07577258
- Acronym / sponsor ID
- HA35-PERI / HA35202607
- Conditions
- Mild Gingival Recession, Periodontal Inflammation, Chronic Gingival Pain, Gingival Redness and Swelling, Gingival Bleeding
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Gingival Recession, Periodontal Disease, Gingival Pain, Gingival Bleeding, Gingival Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA35 Topical Gingival Gel Group | Experimental | Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical GelParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical GelAlso: HA35 Periodontal Gel, Gingival Repair HA35 GelTopical 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. | Device | HA35 Topical Gingival Gel Group |
Primary outcome
Change in Gingival Recession Depth (mm)
Time frame: 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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel in people with Mild Gingival Recession and Periodontal Inflammation, run by Nakhia Impex LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Recession Depth (mm) (time frame: Baseline to Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.