The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: The novel electrolyzed water spray

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qingdao, China
    • Huinuode Biotechnology Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The mild periodontitis and one treatment; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dove Medical Press Ltd
• Collaborators: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Periodontitis; gingival bleeding; Spray; Electrolyzed water device; Hydroxyl radical; Tap water; gingival redness; gingival swelling
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: jia19681222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: until publication of this clinical study and international patent granted
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No