HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Overview

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.

Full Title of Study: “EVALUATION OF THE HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTI-PLAQUE AGENT. A RANDOMIZED CONTROLLED TRIAL”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 15, 2016

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: HOCl 0.025%
    • 15 ml of Hypochlorous acid mouthwash at 0.025%
  • Experimental: HOCl 0.05%
    • 15 ml of Hypochlorous acid mouthwash at 0.05%
  • Active Comparator: CHX 0.2%
    • 15 ml of chlorhexidine mouthwash at 0.2%
  • Active Comparator: CHX 0.025%
    • 15 ml of chlorhexidine at mouthwash0.025%
  • Placebo Comparator: Placebo
    • 15 ml of Sterile water

Clinical Trial Outcome Measures

Primary Measures

  • Substantivity
    • 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.

Secondary Measures

  • Plaque Index
    • Time Frame: Baseline and 7 hours
    • Visible plaque was evaluated by Turesky Index 1970

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidad El Bosque, Bogotá
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gloria Inés Lafaurie, Magister Clinical Epidemiology – Universidad El Bosque, Bogotá
  • Overall Official(s)
    • Gloria Ines Lafaurie, MS, Principal Investigator, El Bosque University

Citations Reporting on Results

Lafaurie GI, Calderón JL, Zaror C, Millán LV, Castillo DM. Hypochlorous Acid: A New Alternative as Antimicrobial Agent and For Cell Proliferation for Use in Dentistry. International journal of odontostomatology. 9: 475-481. 2015

Castillo DM, Castillo Y, Delgadillo NA, Neuta Y, Jola J, Calderon JL, Lafaurie GI. Viability and Effects on Bacterial Proteins by Oral Rinses with Hypochlorous Acid as Active Ingredient. Braz Dent J. 2015 Oct;26(5):519-24. doi: 10.1590/0103-6440201300388.

Chen CJ, Chen CC, Ding SJ. Effectiveness of Hypochlorous Acid to Reduce the Biofilms on Titanium Alloy Surfaces in Vitro. Int J Mol Sci. 2016 Jul 19;17(7):1161. doi: 10.3390/ijms17071161.

Moran J, Addy M, Wade W, Milson S, McAndrew R, Newcombe RG. The effect of oxidising mouthrinses compared with chlorhexidine on salivary bacterial counts and plaque regrowth. J Clin Periodontol. 1995 Oct;22(10):750-5. doi: 10.1111/j.1600-051x.1995.tb00257.x.

Wang L, Bassiri M, Najafi R, Najafi K, Yang J, Khosrovi B, Hwong W, Barati E, Belisle B, Celeri C, Robson MC. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr 11;6:e5.

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