Clinical trial NCT03329105: Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health
Official title: Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health in a Group of Young Adults: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Gingivitis
Chronic Gingivitis, Plaque Induced
Keywords: Gingival Health
Biofilm Formation
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Turesky modification of Quigley-Hein plaque index
timeFrame: Change from Baseline at 1 Month
measure: Presence or absence of gingival bleeding
timeFrame: Baseline and 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: College of Dentistry, University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Professor, College of Dentistry
name: Jay Hoover
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.