HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)


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This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gloria Inés Lafaurie, Universidad El Bosque, Bogotá

ClinicalTrials.gov Identifier:

NCT03174756

First received: May 31, 2017

Last updated: May 31, 2017

Last verified: May 2017

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.

Hypochlorous Acid
Mouthwashes
Drug: Hypochlorous Acid
Drug: Chlorhexidine
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: 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: 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

Primary Outcome Measures:

Secondary Outcome Measures:

Other Outcome Measures:

  • 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.

Enrollment: 75
Actual Study Start Date: January 15, 2015
Study Completion Date: November 30, 2016
Primary Completion Date: November 15, 2016 (Final data collection date for primary outcome measure)
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

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. The effect of each rinse on bacterial viability over time was evaluated by repeated measures ANOVA, adjusted to time, treatment and time-treatment interaction. The difference in plaque index between groups at 7 hours was analyzed by one-way ANOVA.

Ages Eligible for Study:   18 Years to 25 Years   (Adult)
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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03174756

Gloria Ines Lafaurie
Bogotá, Colombia, 1101

Universidad El Bosque, Bogotá

Principal Investigator: Gloria Ines Lafaurie, MS El Bosque University

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

Responsible Party: Gloria Inés Lafaurie, Magister Clinical Epidemiology, Universidad El Bosque, Bogotá
ClinicalTrials.gov Identifier: NCT03174756     History of Changes
Other Study ID Numbers: Ubosque
Study First Received: May 31, 2017
Last Updated: May 31, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No requerid

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:

Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 02, 2017