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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Gingivitis; Chronic Gingivitis, Plaque Induced
• Intervention / Treatment: Other: Sea Salt Mouth Rinse; Other: Standardized Oral Health Practices

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5E4
      • College of Dentistry, University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sea Salt Mouth Rinse	Other: 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.; 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
Active Comparator: Standardized Oral Health Practices	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turesky modification of Quigley-Hein plaque index	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.	Change from Baseline at 1 Month
Presence or absence of gingival bleeding	Presence or absence of gingival bleeding on gentle probing to determine gingival health	Baseline and 1 Month

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Jay Hoover, Professor, College of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): August 24, 2017
• Study Completion (Actual): August 24, 2017

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Gingival Health; Biofilm Formation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Chronic Disease
• Other Study ID Numbers: 16-272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No