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

Chronic Gingivitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329105
• Other study ID #: 16-272
• Status: Completed
• Phase: N/A
• First received: October 17, 2017
• Last updated: October 30, 2017
• Start date: November 7, 2016
• Est. completion date: August 24, 2017

Study information

• Verified date: October 2017
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Gingivitis
• Chronic Gingivitis, Plaque Induced
• Gingivitis

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	College of Dentistry, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Albandar JM, Rams TE. Global epidemiology of periodontal diseases: an overview. Periodontol 2000. 2002;29:7-10. — View Citation

Axelsson P, Lindhe J, Nyström 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. — View 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. — View Citation

Brecx M. Strategies and agents in supragingival chemical plaque control. Periodontol 2000. 1997 Oct;15:100-8. Review. — View 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. Review. — View Citation

Jackson RJ. Metal salts, essential oils and phenols--old or new? Periodontol 2000. 1997 Oct;15:63-73. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Presence or absence of gingival bleeding	Presence or absence of gingival bleeding on gentle probing to determine gingival health	Baseline and 1 Month