The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Device: The novel electrolyzed water spray

• Registration Number: NCT05770258
• Lead Sponsor: Dove Medical Press Ltd

Brief Summary

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

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 Timeline

• Study Start: 2023-01-29
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-15
• Primary Completion: 2023-07-20
• Study Completion: 2024-01-20
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The mild periodontitis and one treatment	The novel electrolyzed water spray	Participants with mild periodontitis accompanied by gingival discomfort will receive one treatment with the device and complete the questionnaire.

Primary Outcome Measures

Name	Time	Method
A discomfort or itching scale made by modifying the Numeric Pain Rating Scale (NPRS)	10 days	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".

Secondary Outcome Measures

Name	Time	Method
A gingival signs scale made by modifying the Numeric Pain Rating Scale (NPRS).	10 days	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.

Trial Locations

Locations (1)

Huinuode Biotechnology Co., Ltd.; 🇨🇳 Qingdao, China