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HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

NCT ID: NCT03174756

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-15

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypochlorous Acid Mouthwashes

Keywords

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Hypochlorous Acid Chlorhexidine Antiplaque agents Substantivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The treatment codes of the study were not accessible to the investigators and to the examiner until the data were analyzed

Study Groups

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HOCl 0.025%

15 ml of Hypochlorous acid mouthwash at 0.025%

Group Type EXPERIMENTAL

Hypochlorous Acid

Intervention Type DRUG

Mouthwashes of antiplaque agents

HOCl 0.05%

15 ml of Hypochlorous acid mouthwash at 0.05%

Group Type EXPERIMENTAL

Hypochlorous Acid

Intervention Type DRUG

Mouthwashes of antiplaque agents

CHX 0.2%

15 ml of chlorhexidine mouthwash at 0.2%

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

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

CHX 0.025%

15 ml of chlorhexidine at mouthwash0.025%

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

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

Placebo

15 ml of Sterile water

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sterile water as placebo

Interventions

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Hypochlorous Acid

Mouthwashes of antiplaque agents

Intervention Type DRUG

Chlorhexidine

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

Intervention Type DRUG

Placebo

Sterile water as placebo

Intervention Type OTHER

Other Intervention Names

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HClO Hypochlorous Acids CHX Placebos

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad El Bosque, Bogotá

OTHER

Sponsor Role lead

Responsible Party

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Gloria Inés Lafaurie

Magister Clinical Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gloria Ines Lafaurie, MS

Role: PRINCIPAL_INVESTIGATOR

El Bosque University

Locations

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Gloria Ines Lafaurie

Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 26647939 (View on PubMed)

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.

Reference Type RESULT
PMID: 27447617 (View on PubMed)

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.

Reference Type RESULT
PMID: 8682921 (View on PubMed)

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.

Reference Type RESULT
PMID: 17492050 (View on PubMed)

Other Identifiers

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Ubosque

Identifier Type: -

Identifier Source: org_study_id