Skip to main content
OpenTrials
Completed

NCT Number: NCT05770258

The Novel Electrolyzed Water Spray Treatment Mild Periodontitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Gingival Diseases Gingival Hemorrhage Hemorrhage Mouth Diseases Oral Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

36 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huinuode Biotechnology Co., Ltd.

Qingdao, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The novel electrolyzed water spray

Device

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.

Primary outcomes

  1. A discomfort or itching scale made by modifying the Numeric Pain Rating Scale (NPRS)

    Time frame: 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 outcomes

  1. A gingival signs scale made by modifying the Numeric Pain Rating Scale (NPRS).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dove Medical Press Ltd

Network

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.