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

Gingivitis Clinical Trial

Official title:

Evaluation of a Mouthwash Formulation Containing Neutral Electrolysed Water on De-novo Plaque Formation, Gingival Inflammation, MMP-8 Activity and the Oral Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05709015
• Other study ID #: EOWG
• Status: Completed
• Phase: Phase 2
• Start date: January 5, 2023
• Est. completion date: June 21, 2023

Study information

• Verified date: January 2023
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

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

Locations

Country	Name	City	State
Slovenia	University of Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D plaque score	Differences in plaque scores evaluated by optical scanning	baseline, 4 days
Primary	Plaque index	Differences on plaque score evaluated using the Turesky Modification of the Quigley-Hein Plaque Index	baseline, 4 days
Secondary	Modified Gingival Index	Differences in the gingival index evaluated using the Lobene Modified Gingival Index	baseline, 4 days
Secondary	Microbiologic profile of gingival crevicular fluid	To determine if the mouthwashes effect the presence of the most relevant periodontal pathogens (e. g. Aggregibacter actinomycetemcomitans) in gingival crevicular fluid	baseline, 4 days
Secondary	MMP-8 in gingival crevicular fluid	To determine if the mouthwashes effect the amount of MMP-8 in gingival crevicular fluid	baseline, 4 days