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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Gingival Pain NRS Score (0-10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HA35 Gel Topical Application Group
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.
干预措施: 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel (Device)
结局指标
主要结局
Change in Gingival Pain NRS Score (0-10)
时间窗: 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.
次要结局
- Change in Gingival Swelling Severity (0-10 VAS Score)(Baseline to 1, 30, and 60 minutes after application)
- Onset Time of Gingival Pain Relief(Within 60 minutes after application)
- Incidence and Severity of Oral Adverse Events(Throughout the 60-minute observation period)