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Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health

Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health in a Group of Young Adults: A Pilot Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03329105
Enrollment
30
Registered
2017-11-01
Start date
2016-11-07
Completion date
2017-08-24
Last updated
2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Gingivitis, Chronic Gingivitis, Plaque Induced

Keywords

Gingival Health, Biofilm Formation

Brief summary

This study evaluates the addition of a mouth rinse containing sea salt, xylitol and lysozyme to standardized oral health practices on biofilm formation and gingival health in a group of young adults.

Detailed description

The purpose of this study is to evaluate a new sea salt mouth rinse containing xylitol and the antibacterial enzyme, lysozyme on biofilm formation and gingival health in a group of young adults. Xylitol is a well-established non-sugar sweetener and an anti-caries agent. The use of this polyol results in loosely adherent biofilms by reducing the amount of extracellular lipopolysaccharides and lipoteichoic acids, facilitating its easy removal by mechanical means. Lysozymes are antibacterial proteins that hydrolyze the linkage between N-acetylmuramic acid and N-acetylglucosamine of peptidoglycan in the cell wall of Gram + bacteria effectively limiting growth.

Interventions

OTHERSea Salt Mouth Rinse

Rinsing mouth with a tablespoon of sea salt mouth rinse without any dilution, for 30 seconds, once in the morning and once before bed, in addition to Standardized Oral Health Practices.

OTHERStandardized Oral Health Practices

Brushing teeth for two minutes using the modified Bass technique, twice per day with the provided dentifrice, and flossing once daily using the spool method

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 26 Years
Healthy volunteers
Yes

Inclusion criteria

* Dentate * Medically healthy * No orthodontic bands * An anticipated ability to attend the two scheduled visits

Exclusion criteria

* Significant medical condition (including but not limited to, poorly controlled diabetes mellitus, rheumatic heart disease or clinically significant heart murmur) * Pregnancy * Recent history of, or ongoing, antibiotic therapy

Design outcomes

Primary

MeasureTime frameDescription
Turesky modification of Quigley-Hein plaque indexChange from Baseline at 1 MonthEvaluation of plaque scores on six representative teeth: 16, 21, 24, 36, 41 & 44, using an index that evaluates the plaque revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5, defined by G. A. Quigley and J. W. Hein in 1962 and modified by S. Turesky, N. D. Gilmore, and I. Glickman in 1970.
Presence or absence of gingival bleedingBaseline and 1 MonthPresence or absence of gingival bleeding on gentle probing to determine gingival health

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026