Efficacy and Safety of HA35 Gel for Mild Gingival Recession and Periodontal Inflammation (HA35-PERI)
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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Gingival Recession Depth (mm)
大体时间：Baseline to Day 42
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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.
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Baseline to Day 42
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Chronic Gingival/Radicular Pain Intensity (0-10 NRS)
大体时间：Baseline to Day 42
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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.
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Baseline to Day 42
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Change in Gingival Itching/Discomfort Intensity (0-10 NRS)
大体时间：Baseline to 30 seconds after first application
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Change in gingival itching or discomfort intensity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no discomfort and 10 = maximum discomfort.
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Baseline to 30 seconds after first application
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Change in Gingival Redness and Swelling Severity (0-10 Scale)
大体时间：Baseline to Day 4
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Change in gingival redness and swelling severity, assessed using a 0-10 ordinal scale, where 0 = normal gingiva and 10 = severe redness and swelling.
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Baseline to Day 4
|
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Resolution Rate of Brushing-Induced Gingival Bleeding
大体时间：Baseline to Day 2
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Proportion of participants with complete resolution of brushing-induced gingival bleeding, defined as no bleeding observed during gentle tooth brushing.
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Baseline to Day 2
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Incidence and Severity of Oral Adverse Events
大体时间：Throughout the 42-day treatment period
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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).
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Throughout the 42-day treatment period
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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