Hypochlorous Acid Mouthwash, Oral Bacteria, and Staphylococcus Aureus

NCT05372835 | Completed

• 1 other identifier: KMUHIRB-F(I)-20200042
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Mouthwash is one method of maintain oral health and to reduce the dental plaque and gum inflammation. However, the effects of mouthwash on oral bacteria were not consistent among different brands of them. The aims of present study were to determine the effects of a new designed mouthwash with hypochlorous acid on oral bacteria and Staphylococcus aureus. All participants were invited as a volunteer to attend this study from a private dental clinic and diagnosed by the same dentist. Patients with periodontal diseases were randomized selected as mouthwash group and mouthwash plus dental flossing device (La Chlogen, Taiwan) group. Patients for regular dental visit and without periodontal disease were invited as a control group having mouth rinse with water. After the inform consent was signed, participants completed the intervention study, saliva collection, and a simple survey under the guide of a dental assistant. Saliva samples were collected before and after the intervention for bacterial DNA extraction. A real-time polymerase chain reaction and S. aureus with serial dilutions were applied for the estimation of total oral bacterial count (TOBC) in saliva. An in vitro assay with CCK-8 reagent was apply to test the antibacterial ability of mouthwash.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (3)

• Total oral bacterial count before the intervention

  Before the intervention, saliva samples were collected for oral bacterial DNA extraction.The saliva volume and weight of each sample was also recorded before the bacterial genomic DNA extraction process. A real-time polymerase chain reaction and S. aureus with serial dilutions were applied for the estimation of total oral bacterial count (TOBC) in saliva. The differences in TOBC among the mouthwash group (MW), mouthwash and periodontal flosser group (MWF), and control group were determined using statistical analysis.

  Before the intervention starting

• Total oral bacterial count after the intervention

  After the intervention, saliva samples were collected for oral bacterial DNA extraction. The saliva volume and weight of each sample was also recorded before the bacterial genomic DNA extraction process. A real-time polymerase chain reaction and S. aureus with serial dilutions were applied for the estimation of total oral bacterial count (TOBC) in saliva. The difference in TOBC between before and after intervention was determined using statistical analysis

  Immediately after the intervention

• Survival rate of S. aureus after the incubation with 10% (v/v) mouthwash

  An in vitro assay and CCK-8 reagent were applied to determine the survival rates of 1000000 and 10000000 CFU/mL of S. aureus after being incubated with 10% (v/v) mouthwash. These results could indicate the anti-bacterial ability of mouthwash to S. aureus.

  One week after the intervention

Secondary Outcomes (1)

• The percentage change in the TOBC after the intervention

  One month after the intervention

Study Arms (3)

mouthwash

EXPERIMENTAL

The 15 mL of commercially available La Chlogen mouthwash (Republic of China Patent No. M616466) was used for intervention to rinse in mouth for 5 minutes. The main ingredient in the mouthwash is low-concentration high-purity HOCl (100 ppm) solution.

Other: La Chlogen mouthwash

mouthwash and periodontal flosser

EXPERIMENTAL

The 15 ml of commercially available La Chlogen mouthwash (Republic of China Patent No. M616466) in conjunction with the La Chlogen periodontal flosser (Republic of China Patent No. M590033) were used for intervention in the mouth for 5 minutes. The main ingredient in the mouthwash is low-concentration high-purity HOCl (100 ppm) solution.

Other: La Chlogen mouthwash and La Chlogen periodontal flosser

control

PLACEBO COMPARATOR

The pure water without HOCl chemical was applied in this intervention to rinse in mouth for 5 minutes.

Other: water

Interventions

La Chlogen mouthwash OTHER

Patients with periodontal disease were randomized into mouthwash group. Before the intervention, participants were asked to rinse 5 ml of water to deplete the food debris and the other residues. After this, the intervention was asked participants to rinse the commercially available La Chlogen mouthwash in mouth without spitting. After 5 minutes, the participants spit out the liquid, and the saliva samples were collected for further analysis.

mouthwash

water OTHER

Patients without periodontal disease were selected as a control group. Before the intervention, participants were asked to rinse 5 ml of water to deplete the food debris and the other residues. After this, the intervention was asked participants to rinse the pure water in mouth without spitting. After 5 minutes, the participants spit out the liquid, and the saliva samples were collected for further analysis.

control

La Chlogen mouthwash and La Chlogen periodontal flosser OTHER

Patients with periodontal disease were randomized into mouthwash and periodontal flosser group. Before the intervention, participants were asked to rinse 5 ml of water to deplete the food debris and the other residues. After this, the La Chlogen mouthwash in conjunction with the La Chlogen periodontal flosser were applied in mouth without spitting for interventions. After 5 minutes, the participants spit out the liquid, and the saliva samples were collected for further analysis.

mouthwash and periodontal flosser

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the participants were between 35 and 70 years old.
• Clinical diagnosis of periodontal disease
• Must be able to rinse liquid (mouthwash or water) in mouth and split out saliva into a collection tube

You may not qualify if:

• diagnosed mental illness
• incapacitated patients
• antibiotics or immunosuppressive drugs taken for the two consecutive weeks preceding study commencement
• pregnant
• smokers
• cancers
• Insulin dependent diabetes

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Private Wenhsin Dental Clinic

Kaohsiung City, 806, Taiwan

Location

Related Publications (1)

• Lin YC, Tsai CF, Huang HL. Effects of hypochlorous acid mouthwash on salivary bacteria including Staphylococcus aureus in patients with periodontal disease: a randomized controlled trial. BMC Oral Health. 2023 Sep 28;23(1):698. doi: 10.1186/s12903-023-03358-4.

  PMID: 37770865 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Water

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Hsian-Ling Huang, Ph.D.

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

• Ying-Chu Lin, Ph.D.

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants have no idea in the usage of mouthwash or water. Participant with and without periodontal disease was blinded for the laboratory determining total oral bacterial count in saliva samples.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The volunteers of patients with and without periodontal disease were recruited in the same day. Patients with periodontal disease were randomized into mouthwash group and mouthwash plus periodontal flosser group. Patients without periodontal disease were recruited as the control group.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 13, 2022
• Study Start: March 20, 2020
• Primary Completion: February 7, 2022
• Study Completion: February 22, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)