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HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Sponsor
Universidad El Bosque, Bogotá (Other)
Overall Status
Completed
CT.gov ID
NCT03174756
Collaborator
(none)
75
Enrollment
1
Location
5
Arms
22.5
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A double-blind randomized controlled trial with 75 participants was conducted. Participants were 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 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.A double-blind randomized controlled trial with 75 participants was conducted. Participants were 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 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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The treatment codes of the study were not accessible to the investigators and to the examiner until the data were analyzed
Primary Purpose:
Treatment
Official Title:
EVALUATION OF THE HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTI-PLAQUE AGENT. A RANDOMIZED CONTROLLED TRIAL
Actual Study Start Date :
Jan 15, 2015
Actual Primary Completion Date :
Nov 15, 2016
Actual Study Completion Date :
Nov 30, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Substantivity [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 Outcome Measures

    1. Plaque Index [Baseline and 7 hours]

      Visible plaque was evaluated by Turesky Index 1970

    Other Outcome Measures

    1. Adverse effect [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gloria Ines Lafaurie Bogotá Colombia 1101

    Sponsors and Collaborators

    • Universidad El Bosque, Bogotá

    Investigators

    • Principal Investigator: Gloria Ines Lafaurie, MS, El Bosque University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gloria Inés Lafaurie, Magister Clinical Epidemiology, Universidad El Bosque, Bogotá
    ClinicalTrials.gov Identifier:
    NCT03174756
    Other Study ID Numbers:
    • Ubosque
    First Posted:
    Jun 2, 2017
    Last Update Posted:
    Oct 26, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Gloria Inés Lafaurie, Magister Clinical Epidemiology, Universidad El Bosque, Bogotá
    Hypochlorous Acid
    Chlorhexidine
    Antiplaque agents
    Substantivity
    Additional relevant MeSH terms:
    Chlorhexidine

    Study Results

    No Results Posted as of Oct 26, 2017