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

NCT ID: NCT05709015

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2023-06-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1

Based on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table).

Group Type: OTHER

Neutral electrolyzed water

Intervention Type: OTHER

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

Placebo

Intervention Type: DRUG

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

Chlorhexidine digluconate

Intervention Type: DRUG

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

2

Based on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table).

Group Type: OTHER

Neutral electrolyzed water

Intervention Type: OTHER

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

Placebo

Intervention Type: DRUG

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

Chlorhexidine digluconate

Intervention Type: DRUG

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

3

Based on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table).

Group Type: OTHER

Neutral electrolyzed water

Intervention Type: OTHER

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

Placebo

Intervention Type: DRUG

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

Chlorhexidine digluconate

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

Placebo

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 20 - 30 years,
• non-smoker,
• systemically healthy,
• without regular systemic medication,
• presence of at least 6 teeth in each jaw quadrant,
• plaque index < 10 % at baseline visit,
• absence of periodontal pockets measuring > 4 mm.

Exclusion Criteria

• known allergy or suspected hypersensitivity to chlorhexidine digluconate,
• gingivitis,
• regularly use of mouthwash as part of oral hygiene routine,
• antibiotic treatment in the last 6 months or during the observation period,
• pregnancy or lactation,
• fixed or removable prosthetic devices, dental implants.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

EOWG

Identifier Type: -

Identifier Source: org_study_id