HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Study Overview
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Brief Summary
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Hypochlorous acid (HOCl) in a non-antibiotic antimicrobial agent used in clinical medicine. Nevertheless, its antiplaque oral effect has not been evaluated. Chlorhexidine (CHX) is the gold standard as an antiplaque agent for its high substantivity in plaque and saliva. There are no published studies evaluating the substantivity of hypochlorous acid compared to CHX. Objective: To evaluate the efficacy of mouthwashes of HOCl in substantivity evaluated by reduction of bacterial viability in saliva during 7 hours compared to CHX rinses and a placebo.

Detailed Description
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Materials and Methods: A randomized, double-blind clinical trial with 75 participants was conducted. Participants were randomly assigned using block randomization in five groups: HOCl 0.025% and 0.05%, CHX 0.12 and 0.2% and sterile water as placebo. Participants were instructed to use each rinse with 10 ml of each solution for 30 seconds after dental prophylaxis. Samples of saliva were taken at baseline and after 30 seconds, 1, 3.5 and 7 hours to assess substantivity establishing the bacterial viability by the fluorescence method with the SYTO 9/propidium iodide dual staining. All participants were assessed with the Turesky visible plaque index at baseline and at 7 hours and adverse events were assessed. For the comparisons of the viability of the different rinses between times, the statistical test of generalized linear mixed model [GT1] adjusted to treatment, time and treatment-time interaction was used.

Official Title
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EVALUATION OF THE HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTI-PLAQUE AGENT. A RANDOMIZED CONTROLLED TRIAL

Conditions
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Hypochlorous Acid, Mouthwashes

Intervention / Treatment
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* Drug: Hypochlorous Acid
* Drug: Chlorhexidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dentate young men with minimum 22 teeth were considered eligible for the study. Participants should have good dental and gingival status (DMFT index ≤ 3, median of Lobene gingival index ≤ 1) and detectable levels of dental plaque at 7 hours of brushing during the selection process. Exclusion Criteria: Exclusion criteria included smoking, orthodontic, orthopedic or rehabilitation treatment, cavitated carious lesions and consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind randomized controlled trial with 75 participants was conducted. Participants were assigned using block randomization in five groups: HOCl 0.025% and 0.05%, CHX 0.12% and 0.2% and sterile water as placebo. Participants were instructed to use each rinse solution for 30 seconds after dental prophylaxis. Samples of saliva were taken at baseline and after 30 seconds, 1, 3.5 and 7 hours to assess substantivity establishing the bacterial viability by the fluorescence method.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOCl 0.025%<br>15 ml of Hypochlorous acid mouthwash at 0.025% | Drug: Hypochlorous Acid<br>* Mouthwashes of antiplaque agents<br>* Other names: Hypochlorous Acids;|
| Experimental: HOCl 0.05%<br>15 ml of Hypochlorous acid mouthwash at 0.05% | Drug: Hypochlorous Acid<br>* Mouthwashes of antiplaque agents<br>* Other names: Hypochlorous Acids;|
| Active Comparator: CHX 0.2%<br>15 ml of chlorhexidine mouthwash at 0.2% | Drug: Chlorhexidine<br>* A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.<br>* Other names: CHX;|
| Active Comparator: CHX 0.025%<br>15 ml of chlorhexidine at mouthwash0.025% | Drug: Chlorhexidine<br>* A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.<br>* Other names: CHX;|
| Placebo Comparator: Placebo<br>15 ml of Sterile water | Other: Placebo<br>* Sterile water as placebo<br>* Other names: Placebos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substantivity | Viability reduction (VR) was calculated for each saliva sample by the difference in the percentage of viable bacteria between two times. | Baseline, 30 Seconds, 1, 3, 5 and 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Visible plaque was evaluated by Turesky Index 1970 | Baseline and 7 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypochlorous Acid, Chlorhexidine, Antiplaque agents, Substantivity