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

NCT05709015 | Completed Phase 2

• 1 other identifier: EOWG
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 3D plaque score

  Differences in plaque scores evaluated by optical scanning

  baseline, 4 days

• Plaque index

  Differences on plaque score evaluated using the Turesky Modification of the Quigley-Hein Plaque Index

  baseline, 4 days

Secondary Outcomes (3)

• Modified Gingival Index

  baseline, 4 days

• Microbiologic profile of gingival crevicular fluid

  baseline, 4 days

• MMP-8 in gingival crevicular fluid

  baseline, 4 days

Study Arms (3)

1

OTHER

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).

Other: Neutral electrolyzed water; Drug: Placebo; Drug: Chlorhexidine digluconate

2

OTHER

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).

Other: Neutral electrolyzed water; Drug: Placebo; Drug: Chlorhexidine digluconate

3

OTHER

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).

Other: Neutral electrolyzed water; Drug: Placebo; Drug: Chlorhexidine digluconate

Interventions

Neutral electrolyzed water OTHER

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

1; 2; 3

Placebo DRUG

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

1; 2; 3

Chlorhexidine digluconate DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University of Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Povsic K, Munjakovic H, Zayed N, Teughels W, Seme K, Fidler A, Gaspersic R. Electrolyzed saline as an alternative to chlorhexidine: Antimicrobial and biofilm volume outcomes in a 4-day non-brushing randomized controlled clinical trial. J Periodontol. 2026 Feb 2. doi: 10.1002/jper.70070. Online ahead of print.

  PMID: 41627021 DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: January 5, 2023
• Primary Completion: February 21, 2023
• Study Completion: June 21, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-01

Locations

SL (1)