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

NCT ID: NCT03329105

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2017-08-24

Brief Summary

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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

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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.

Conditions

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Chronic Gingivitis Chronic Gingivitis, Plaque Induced

Keywords

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Gingival Health Biofilm Formation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sea Salt Mouth Rinse

Group Type EXPERIMENTAL

Sea Salt Mouth Rinse

Intervention Type 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

Intervention Type 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

Standardized Oral Health Practices

Group Type ACTIVE_COMPARATOR

Standardized Oral Health Practices

Intervention Type 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

Interventions

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Sea 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.

Intervention Type OTHER

Standardized 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jay Hoover

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jay Hoover

Role: PRINCIPAL_INVESTIGATOR

Professor, College of Dentistry

Locations

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College of Dentistry, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Albandar JM, Rams TE. Global epidemiology of periodontal diseases: an overview. Periodontol 2000. 2002;29:7-10. doi: 10.1034/j.1600-0757.2002.290101.x. No abstract available.

Reference Type BACKGROUND
PMID: 12102700 (View on PubMed)

Burt B; Research, Science and Therapy Committee of the American Academy of Periodontology. Position paper: epidemiology of periodontal diseases. J Periodontol. 2005 Aug;76(8):1406-19. doi: 10.1902/jop.2005.76.8.1406. No abstract available.

Reference Type BACKGROUND
PMID: 16101377 (View on PubMed)

Axelsson P, Lindhe J, Nystrom B. On the prevention of caries and periodontal disease. Results of a 15-year longitudinal study in adults. J Clin Periodontol. 1991 Mar;18(3):182-9. doi: 10.1111/j.1600-051x.1991.tb01131.x.

Reference Type BACKGROUND
PMID: 2061418 (View on PubMed)

Bizarra F, Ribeiro S. Improving toothbrushing behaviour in an institution for the disabled in Lisbon, Portugal. Int J Dent Hyg. 2009 Aug;7(3):182-7. doi: 10.1111/j.1601-5037.2009.00387.x.

Reference Type BACKGROUND
PMID: 19659714 (View on PubMed)

Litonjua LA, Cabanilla LL, Abbott LJ. Plaque formation and marginal gingivitis associated with restorative materials. Compend Contin Educ Dent. 2011 May;32(4):e69-72.

Reference Type BACKGROUND
PMID: 23738894 (View on PubMed)

Brecx M. Strategies and agents in supragingival chemical plaque control. Periodontol 2000. 1997 Oct;15:100-8. doi: 10.1111/j.1600-0757.1997.tb00109.x. No abstract available.

Reference Type BACKGROUND
PMID: 9643237 (View on PubMed)

Jackson RJ. Metal salts, essential oils and phenols--old or new? Periodontol 2000. 1997 Oct;15:63-73. doi: 10.1111/j.1600-0757.1997.tb00106.x. No abstract available.

Reference Type BACKGROUND
PMID: 9643234 (View on PubMed)

Other Identifiers

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16-272

Identifier Type: -

Identifier Source: org_study_id