HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP) (HOCl-SAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Mouthwashes; Hypochlorous Acid
• Intervention / Treatment: Drug: Hypochlorous Acid; Drug: Chlorhexidine; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 1101
    • Gloria Ines Lafaurie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effect	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.	24 hours

Collaborators and Investigators

• Sponsor: Universidad El Bosque, Bogotá
• Investigators: Principal Investigator: Gloria Ines Lafaurie, MS, El Bosque University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): November 15, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Chlorhexidine; Hypochlorous Acid; Antiplaque agents; Substantivity
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: Ubosque

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No requerid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No