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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Gingival Recession Depth (mm)
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 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.
详细描述
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.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HA35 Topical Gingival Gel Group
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.
干预措施: 10% High-Concentration 35 kDa Hyaluronan (HA35) Gingival Topical Gel (Device)
结局指标
主要结局
Change in Gingival Recession Depth (mm)
时间窗: 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.
次要结局
- Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)(Baseline to Day 42)
- Change in Gingival Itching/Discomfort Intensity (0-10 NRS)(Baseline to 30 seconds after first application)
- Change in Gingival Redness and Swelling Severity (0-10 Scale)(Baseline to Day 4)
- Resolution Rate of Brushing-Induced Gingival Bleeding(Baseline to Day 2)
- Incidence and Severity of Oral Adverse Events(Throughout the 42-day treatment period)