Post-Dental Gingival PainHA35NCT07584655
Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling
A study testing 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel in people with Post-Dental Gingival Pain and Gingival Swelling, 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 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls in patients with gingival pain and swelling after dental procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Dental Gingival Pain, Gingival Swelling, Postoperative Oral Pain
- What is being tested?
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years, male or female
- Experienced gingival pain and swelling within 12 hours after dental procedures
- Baseline gingival pain NRS score ≥2
- Able to independently complete pain and swelling assessments
- Signed written informed consent
Who cannot join
- Severe periodontitis, uncontrolled diabetes, or immune dysfunction
- Long-term use of analgesics or anti-inflammatory drugs
- Known hypersensitivity to hyaluronan or gel components
- Oral infection, ulceration, or severe mucosal injury at the application site
- 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 Post-Dental Gingival Pain and Swelling
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls in patients with gingival pain and swelling after dental procedures. Eligible participants will gently chew and retain the gel-soaked cotton balls on the affected area for 30 minutes. The primary objectives are to assess changes in gingival pain and swelling at 1, 30, and 60 minutes after application. Safety and local oral tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.
Read the detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic and anti-inflammatory efficacy of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls for managing gingival pain and swelling following dental procedures (including restoration, transplantation, extraction, and scaling).
Eligible subjects will place HA35 gel-soaked sterile cotton balls on the affected gingival area, gently chew and retain the cotton balls in place for 30 minutes to allow sustained local infiltration. Pain intensity will be assessed using a 0-10 Numeric Rating Scale (NRS), and gingival swelling using a 0-10 Visual Analog Scale (VAS) at baseline, 1 minute, 30 minutes, and 60 minutes after application.
Oral irritation, allergic reactions, and adverse events will be monitored 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
- Post-Dental Gingival Pain, Gingival Swelling, Postoperative Oral Pain, Dental Procedure-Related Discomfort, Periodontal Inflammation
- Being tested
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Gingival Pain, Gingival Swelling, Dental Postoperative Care, Analgesia, Anti-Inflammation, Pilot Clinical Study
- Medical subject headings
- Agnosia
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) Oral Topical GelDevice
Also called HA35 Dental Gel, Gingival Care HA35 Gel
Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment. Delivered via gel-soaked cotton balls that are gently chewed and retained in the mouth for sustained infiltration into the affected gingival area to relieve post-dental pain and reduce swelling.
| Study group | Role | What they receive |
|---|---|---|
| HA35 Gel Topical Application Group | Experimental | Participants receive 10% high-concentration 35 kDa HA35 gel delivered via gel-soaked cotton balls, which are gently chewed and held in the affected gingival area for 30 minutes to allow sustained local infiltration. Efficacy on gingival pain, swelling, and safety will be evaluated. Receives: Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Pain NRS Score (0-10)
Change in post-dental gingival pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
Measured: Baseline to 1, 30, and 60 minutes after application
Secondary outcomes (3)
Change in Gingival Swelling Severity (0-10 VAS Score)
Change in gingival swelling severity at the treatment site, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no swelling and 10 = maximum swelling.
Measured: Baseline to 1, 30, and 60 minutes after application
Onset Time of Gingival Pain Relief
Time from application to the first reported reduction in gingival pain intensity of ≥2 points on a 0-10 Numeric Rating Scale (NRS).
Measured: Within 60 minutes after application
Incidence and Severity of Oral Adverse Events
Number and severity of treatment-related oral adverse events (e.g., irritation, numbness, allergic reaction) reported during the study. Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Throughout the 60-minute observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 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 Post-Dental Gingival PainStudies 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
- NCT07584655
- Sponsor's protocol ID
- HA35202606
- Acronym
- HA35
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 22 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 22 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 Post-Dental Gingival Pain and Swelling
- ClinicalTrials.gov ID
- NCT07584655
- Acronym / sponsor ID
- HA35 / HA35202606
- Conditions
- Post-Dental Gingival Pain, Gingival Swelling, Postoperative Oral Pain, Dental Procedure-Related Discomfort, Periodontal Inflammation
- Keywords
- Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Gingival Pain, Gingival Swelling, Dental Postoperative Care, Analgesia
- 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
- 13 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 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls in patients with gingival pain and swelling after dental procedures. Eligible participants will gently chew and retain the gel-soaked cotton balls on the affected area for 30 minutes. The primary objectives are to assess changes in gingival pain and swelling at 1, 30, and 60 minutes after application. Safety and local oral tolerability will be evaluated throughout the observation period. This is a minimal-risk, non-pharmacological, non-invasive intervention.
Detailed description
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic and anti-inflammatory efficacy of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls for managing gingival pain and swelling following dental procedures (including restoration, transplantation, extraction, and scaling).
Eligible subjects will place HA35 gel-soaked sterile cotton balls on the affected gingival area, gently chew and retain the cotton balls in place for 30 minutes to allow sustained local infiltration. Pain intensity will be assessed using a 0-10 Numeric Rating Scale (NRS), and gingival swelling using a 0-10 Visual Analog Scale (VAS) at baseline, 1 minute, 30 minutes, and 60 minutes after application.
Oral irritation, allergic reactions, and adverse events will be monitored 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 Gel Topical Application Group | Experimental | Device: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical GelParticipants receive 10% high-concentration 35 kDa HA35 gel delivered via gel-soaked cotton balls, which are gently chewed and held in the affected gingival area for 30 minutes to allow sustained local infiltration. Efficacy on gingival pain, swelling, and safety will be evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years, male or female
- Experienced gingival pain and swelling within 12 hours after dental procedures
- Baseline gingival pain NRS score ≥2
- Able to independently complete pain and swelling assessments
- Signed written informed consent
Key exclusion criteria (5 listed)
- Severe periodontitis, uncontrolled diabetes, or immune dysfunction
- Long-term use of analgesics or anti-inflammatory drugs
- Known hypersensitivity to hyaluronan or gel components
- Oral infection, ulceration, or severe mucosal injury at the application site
- Pregnant or lactating women
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) Oral Topical GelAlso: HA35 Dental Gel, Gingival Care HA35 GelTopical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment. Delivered via gel-soaked cotton balls that are gently chewed and retained in the mouth for sustained infiltration into the affected gingival area to relieve post-dental pain and reduce swelling. | Device | HA35 Gel Topical Application Group |
Primary outcome
Change in Gingival Pain NRS Score (0-10)
Time frame: Baseline to 1, 30, and 60 minutes after application
Change in post-dental gingival pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
3 secondary outcomes
Change in Gingival Swelling Severity (0-10 VAS Score)
Time frame: Baseline to 1, 30, and 60 minutes after application
Onset Time of Gingival Pain Relief
Time frame: Within 60 minutes after application
Incidence and Severity of Oral Adverse Events
Time frame: Throughout the 60-minute observation 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 22 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) Oral Topical Gel in people with Post-Dental Gingival Pain and Gingival Swelling, 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 5 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 22 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 Pain NRS Score (0-10) (time frame: Baseline to 1, 30, and 60 minutes after application). 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 22 Sep 2026.