HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

NCT03174756 | Completed Phase 2

• 1 other identifier: Ubosque
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypochlorous Acid; Mouthwashes

Keywords

Hypochlorous Acid; Chlorhexidine; Antiplaque agents; Substantivity

Outcome Measures

Primary Outcomes (1)

• Substantivity

  Viability reduction (VR) was calculated for each saliva sample by the difference in the percentage of viable bacteria between two times.

  Baseline, 30 Seconds, 1, 3, 5 and 7 hours

Secondary Outcomes (1)

• Plaque Index

  Baseline and 7 hours

Other Outcomes (1)

• Adverse effect

  24 hours

Study Arms (5)

HOCl 0.025%

EXPERIMENTAL

15 ml of Hypochlorous acid mouthwash at 0.025%

Drug: Hypochlorous Acid

HOCl 0.05%

EXPERIMENTAL

15 ml of Hypochlorous acid mouthwash at 0.05%

Drug: Hypochlorous Acid

CHX 0.2%

ACTIVE COMPARATOR

15 ml of chlorhexidine mouthwash at 0.2%

Drug: Chlorhexidine

CHX 0.025%

ACTIVE COMPARATOR

15 ml of chlorhexidine at mouthwash0.025%

Drug: Chlorhexidine

Placebo

PLACEBO COMPARATOR

15 ml of Sterile water

Other: Placebo

Interventions

Hypochlorous Acid DRUG

Mouthwashes of antiplaque agents

Also known as: HClO, Hypochlorous Acids

HOCl 0.025%; HOCl 0.05%

Chlorhexidine DRUG

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

Also known as: CHX

CHX 0.025%; CHX 0.2%

Placebo OTHER

Sterile water as placebo

Also known as: Placebos

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead

Study Sites (1)

Gloria Ines Lafaurie

Bogotá, 1101, Colombia

Location

Related Publications (5)

• 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

  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.

  PMID: 26647939 RESULT

• 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.

  PMID: 27447617 RESULT

• 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.

  PMID: 8682921 RESULT

• 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.

  PMID: 17492050 RESULT

MeSH Terms

Interventions

Hypochlorous Acid; Chlorhexidine

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Gloria Ines Lafaurie, MS

  El Bosque University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treatment codes of the study were not accessible to the investigators and to the examiner until the data were analyzed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Magister Clinical Epidemiology

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: January 15, 2015
• Primary Completion: November 15, 2016
• Study Completion: November 30, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)