The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

Sponsor

Dove Medical Press Ltd (Other)

Overall Status

Recruiting

CT.gov ID

NCT05770258

Collaborator

The Affiliated Hospital of Qingdao University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Device: The novel electrolyzed water spray	N/A

Detailed Description

Recently, water spray containing a mixture of dissolved hydroxyl radicals, H2, O2, O3, and hydrogen peroxide were instantly generated by tap water and a novel electrolyzed water device. In brief, the scientists use the abrasion-resistant, heat-resisting conductive diamond material coating the key part of electrolyzed water device to directly make the tap water into a water spray containing a mixture of dissolved hydroxyl radical, H2, O2, O3, hydrogen peroxide, namely the advanced oxidizing water. Importantly, water spray containing a mixture of dissolved hydroxyl radicals, H2, O2, O3, and hydrogen peroxide does not release gaseous ozone <0.1mg/m3 to the immediate environment that meets the requirement of environmental safety. 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. In brief, 14 patients with mild periodontitis accompanied by gingival discomfort, male 7, female 7, average age 52±16 are included. Treatment is to spray the diseased area until half a bottle (200ml) of water is used, 2 times a day, 10 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

An open label, single arm and before and after treatment comparison study

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 29, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.