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Completed

NCT Number: NCT03329105

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

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.

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Key information

Conditions

Chronic Gingivitis Chronic Gingivitis, Plaque Induced

Age range

20 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sea Salt Mouth Rinse

Other

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.

Standardized Oral Health Practices

Other

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

Primary outcomes

  1. Turesky modification of Quigley-Hein plaque index

    Time frame: Change from Baseline at 1 Month

    Evaluation 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.

  2. Presence or absence of gingival bleeding

    Time frame: Baseline and 1 Month

    Presence or absence of gingival bleeding on gentle probing to determine gingival health

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2017
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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