Dental Procedure-Related Discomfort, Gingival Swelling, Periodontal Inflammation, Post-Dental Gingival Pain, Postoperative Oral Pain
Conditions
Keywords
Hyaluronan, 35 kDa Hyaluronan, HA35, Topical Gel, Gingival Pain, Gingival Swelling, Dental Postoperative Care, Analgesia, Anti-Inflammation, Pilot Clinical Study
Brief 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. 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.
Interventions
DEVICE10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical 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.
Sponsors
Nakhia Impex LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Pain NRS Score (0-10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gingival Swelling Severity (0-10 VAS Score) | Baseline to 1, 30, and 60 minutes after application | 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. |
| Onset Time of Gingival Pain Relief | Within 60 minutes after application | Time from application to the first reported reduction in gingival pain intensity of ≥2 points on a 0-10 Numeric Rating Scale (NRS). |
| Incidence and Severity of Oral Adverse Events | Throughout the 60-minute observation period | 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). |
Outcome results
None listed