The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

Study Overview
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Brief Summary
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The purpose of this study is to test whether spraying the tooth of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild periodontitis.

Detailed Description
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In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat mild periodontitis.

Official Title
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A Novel Electrolyzed Water Spray Reduces the Gingival Discomfort as Well as Gingival Redness, Swelling and Bleeding of Patients With Mild Periodontitis: A Clinical Study

Conditions
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Periodontitis

Intervention / Treatment
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* Device: The novel electrolyzed water spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild periodontitis accompanied by gingival discomfort. Patient > 18 years old. Systemically healthy individuals Exclusion Criteria: severe periodontitis. 80 years or older. Patients who take Anticoagulants or Antiplatelet Agents Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 36 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The mild periodontitis and one treatment<br>Participants with mild periodontitis accompanied by gingival discomfort will receive one treatment with the device and complete the questionnaire. | Device: The novel electrolyzed water spray<br>* Study staff will use the novel electrolyzed water spray device and spray for approximately 5 minutes on the participant's diseased area until half a bottle (200ml) of water is used. The patients use electrolyzed water to treat the diseased area, two times a day, for 10 days. The trial consists of 10 study visits (day 1-day 10). The relief of mild periodontitis evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A discomfort or itching scale made by modifying the Numeric Pain Rating Scale (NPRS) | This Score is based on descriptions of the itching that patients rate 0-10 to assess the condition of their gingival with itching. A higher score means a worse outcome. 0 means no itching  and 10 means the most itching. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A gingival signs scale made by modifying the Numeric Pain Rating Scale (NPRS). | A gingival signs scale evaluates the signs of gingival redness, swelling and bleeding in patients with mild periodontitis. This Score is based on descriptions of signs of gingival redness, swelling and bleeding with patients rated 0-10 to assess the condition of mild periodontitis. A higher score means a worse outcome. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrolyzed water device, Hydroxyl radical, Tap water, Spray, Periodontitis, gingival redness, gingival swelling, gingival bleeding