Gloria Ines Lafaurie
Bogotá, 1101, Colombia
NCT Number: NCT03174756
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.
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Notify Me18 year–25 year
Male
Interventional
Phase 2
Bogotá, 1101, Colombia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mouthwashes of antiplaque agents
Other names: HClO, Hypochlorous Acids
A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
Other names: CHX
Sterile water as placebo
Other names: Placebos
Time frame: Baseline, 30 Seconds, 1, 3, 5 and 7 hours
Viability reduction (VR) was calculated for each saliva sample by the difference in the percentage of viable bacteria between two times.
Time frame: Baseline and 7 hours
Visible plaque was evaluated by Turesky Index 1970
Time frame: 24 hours
A survey was applied to each of the patients in order to record if any adverse effects occurred after the use of each of the interventions as burning and pain in the oral mucosa and was investigated by the taste of substances and sensation of dryness. An examiner evaluated the buccal, labial, lingual, pharyngeal and teeth tissues to establish changes and alterations visible to the clinical examination and the presence of candidiasis.
Universidad El Bosque, Bogotá
Other
EVALUATION OF THE HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTI-PLAQUE AGENT. A RANDOMIZED CONTROLLED TRIAL
Acronym: HOCl-SAP
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