HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTIPLAQUE AGENT (HOCl-SAP)

Mouthwashes Clinical Trial

— HOCl-SAP  

Official title:

EVALUATION OF THE HYPOCHLOROUS ACID SUBSTANTIVITY AS ANTI-PLAQUE AGENT. A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174756
• Other study ID #: Ubosque
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2017
• Last updated: October 24, 2017
• Start date: January 15, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: October 2017
• Source: Universidad El Bosque, Bogotá
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 30, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypochlorous Acid
• Mouthwashes

Intervention

Drug:
• Hypochlorous Acid
Mouthwashes of antiplaque agents
• Chlorhexidine
A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.

Other:
• Placebo
Sterile water as placebo

Locations

Country	Name	City	State
Colombia	Gloria Ines Lafaurie	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Universidad El Bosque, Bogotá

Country where clinical trial is conducted

Colombia, 

References & Publications (5)

Castillo DM, Castillo Y, Delgadillo NA, Neuta Y, Jola J, Calderón 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. — View Citation

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). pii: E1161. doi: 10.3390/ijms17071161. — View Citation

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

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. — View Citation

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 imm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effect	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.	24 hours
Primary	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	Plaque Index	Visible plaque was evaluated by Turesky Index 1970	Baseline and 7 hours