Skip to main content
OpenTrials
Completed

NCT Number: NCT03174756

HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Gloria Ines Lafaurie

Bogotá, 1101, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypochlorous Acid

Drug

Mouthwashes of antiplaque agents

Other names: HClO, Hypochlorous Acids

Chlorhexidine

Drug

A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.

Other names: CHX

Placebo

Other

Sterile water as placebo

Other names: Placebos

Primary outcomes

  1. 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 outcomes

  1. Plaque Index

    Time frame: Baseline and 7 hours

    Visible plaque was evaluated by Turesky Index 1970

Other outcomes

  1. Adverse effect

    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.

Sponsors and collaborators

Lead sponsor

Universidad El Bosque, Bogotá

Other

Registry information

Official study title

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

Acronym: HOCl-SAP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.