NCT03174756

HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Universidad El Bosque, Bogotá · Academic / Other
• Sex: Male
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hypochlorous Acid
• Mouthwashes

Interventions

Type	Name	Description
DRUG	Hypochlorous Acid	Mouthwashes of antiplaque agents
DRUG	Chlorhexidine	A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
OTHER	Placebo	Sterile water as placebo

Timeline

• Start date: 2015-01-15
• Primary completion: 2016-11-15
• Completion: 2016-11-30
• First posted: 2017-06-02
• Last updated: 2017-10-26

Locations

1 site across 1 country: Colombia