HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Phase 2

Completed

• Conditions: Hypochlorous Acid; Mouthwashes
• Interventions: Other: Placebo; Drug: Chlorhexidine; Drug: Hypochlorous Acid

• Registration Number: NCT03174756
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-01-15
• Primary Completion: 2016-11-15
• Study Completion: 2016-11-30
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-02
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	15 ml of Sterile water
CHX 0.2%	Chlorhexidine	15 ml of chlorhexidine mouthwash at 0.2%
CHX 0.025%	Chlorhexidine	15 ml of chlorhexidine at mouthwash0.025%
HOCl 0.025%	Hypochlorous Acid	15 ml of Hypochlorous acid mouthwash at 0.025%
HOCl 0.05%	Hypochlorous Acid	15 ml of Hypochlorous acid mouthwash at 0.05%

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Plaque Index	Baseline and 7 hours	Visible plaque was evaluated by Turesky Index 1970

Trial Locations

Locations (1)

Gloria Ines Lafaurie; 🇨🇴 Bogotá, Colombia