HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Universidad El Bosque, Bogotá

Status and phase: Completed; Phase 2

Conditions: Mouthwashes; Hypochlorous Acid

Treatments: Drug: Hypochlorous Acid; Other: Placebo; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03174756

Ubosque

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 5 patient groups, including a placebo group

HOCl 0.025%

Experimental group

Description:

15 ml of Hypochlorous acid mouthwash at 0.025%

Treatment:

Drug: Hypochlorous Acid

HOCl 0.05%

Experimental group

Description:

15 ml of Hypochlorous acid mouthwash at 0.05%

Treatment:

Drug: Hypochlorous Acid

CHX 0.2%

Active Comparator group

Description:

15 ml of chlorhexidine mouthwash at 0.2%

Treatment:

Drug: Chlorhexidine

CHX 0.025%

Active Comparator group

Description:

15 ml of chlorhexidine at mouthwash0.025%

Treatment:

Drug: Chlorhexidine

Placebo

Placebo Comparator group

Description:

15 ml of Sterile water

Treatment:

Other: Placebo