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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gingivitis

Intervention / Treatment
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* Other: Neutral electrolyzed water
* Drug: Placebo
* Drug: Chlorhexidine digluconate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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<br>* Use of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>Drug: Placebo<br>* Use of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>Drug: Chlorhexidine digluconate<br>* Use of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>|
| Other: 2<br>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<br>* Use of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>Drug: Placebo<br>* Use of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>Drug: Chlorhexidine digluconate<br>* Use of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>|
| Other: 3<br>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<br>* Use of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>Drug: Placebo<br>* Use of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>Drug: Chlorhexidine digluconate<br>* Use of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Gingival Index | Differences in the gingival index evaluated using the Lobene Modified Gingival Index | baseline, 4 days | 
| 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 | 
| MMP-8 in gingival crevicular fluid | To determine if the mouthwashes effect the amount of MMP-8 in gingival crevicular fluid | baseline, 4 days |