Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174756
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gloria Inés Lafaurie, Universidad El Bosque, Bogotá

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
Hypochlorous Acid Mouthwashes Drug: Hypochlorous Acid Drug: Chlorhexidine Other: Placebo 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : January 15, 2015
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: CHX

Placebo Comparator: Placebo
15 ml of Sterile water
Other: Placebo
Sterile water as placebo
Other Name: Placebos




Primary Outcome Measures :
  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 Outcome Measures :
  1. Plaque Index [ Time Frame: Baseline and 7 hours ]
    Visible plaque was evaluated by Turesky Index 1970


Other Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174756


Locations
Layout table for location information
Colombia
Gloria Ines Lafaurie
Bogotá, Colombia, 1101
Sponsors and Collaborators
Universidad El Bosque, Bogotá
Investigators
Layout table for investigator information
Principal Investigator: Gloria Ines Lafaurie, MS El Bosque University
Publications of Results:
Layout table for additonal information
Responsible Party: Gloria Inés Lafaurie, Magister Clinical Epidemiology, Universidad El Bosque, Bogotá
ClinicalTrials.gov Identifier: NCT03174756    
Other Study ID Numbers: Ubosque
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No requerid

Layout table for additional information
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, Universidad El Bosque, Bogotá:
Hypochlorous Acid
Chlorhexidine
Antiplaque agents
Substantivity
Additional relevant MeSH terms:
Layout table for MeSH terms
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants