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Plaque Inhibitory Effect of Neutral Electrolysed Water in the Form of a Mouthwash in a 4-day Non-brushing Model

NCT05709015 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-07-13

No results posted yet for this study

Summary

Electrolysed water (EOW) is produced by the electrolysis of sodium chloride in an aqueous solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the cathode. EOW is known to have antimicrobial effects against various microorganisms, including viruses, bacteria, spores and fungi. Its antimicrobial activity is generally attributed to its hypochloric acid content - a product of chlorine gas dissolved in water. Due to its biocompatibility, known uses of EOW include ocular disinfection, nasal irrigation and chronic cutaneous wound care. In the dental setting, it may be used as a mouthwash, disinfectant, irrigant, mouthwash or dental gel.

The aim of this study is to investigate the effect of a mouthwash containing neutral electrolyzed water on plaque accumulation (evaluated using a disclosing agent and an intraoral scanner), gingival inflammation, MMP-8 activity and the oral microbiome. In this double-blind, cross-over, 4-day experimental gingivitis model, each subject will participate in all three arms of the study. Each arm will last 4 days, during which the subjects will be asked to refrain from toothbrushing and the use of interdental cleaning devices. Instead, they will be instructed to rinse their oral cavities twice daily with either EOW, placebo or a positive control (chlorhexidine), according to a randomisation chart (each subject will receive a different mouthwash type in every arm of the study). The outcomes will be assessed at baseline and after 4 days. A washout period of at least 7 days will be implemented between each study arm.

Conditions

  • Gingivitis

Interventions

OTHER

Neutral electrolyzed water

Use of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.

DRUG

Placebo

Use of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.

DRUG

Chlorhexidine digluconate

Use of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.

Sponsors & Collaborators

  • University of Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2023-02-21
Completion
2023-06-21

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709015 on ClinicalTrials.gov