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

Not Applicable

Completed

• Conditions: Chronic Gingivitis, Plaque Induced; Chronic Gingivitis
• Interventions: Other: Sea Salt Mouth Rinse; Other: Standardized Oral Health Practices

• Registration Number: NCT03329105
• Lead Sponsor: University of Saskatchewan

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.

Study Timeline

• Study Start: 2016-11-07
• Primary Completion: 2017-08-24
• Study Completion: 2017-08-24
• Status Verified: 2017-10
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-30
• Last Update Submitted: 2017-10-30
• Study First Posted: 2017-11-01
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sea Salt Mouth Rinse	Standardized Oral Health Practices	-
Standardized Oral Health Practices	Standardized Oral Health Practices	-
Sea Salt Mouth Rinse	Sea Salt Mouth Rinse	-

Primary Outcome Measures

Name	Time	Method
Turesky modification of Quigley-Hein plaque index	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.
Presence or absence of gingival bleeding	Baseline and 1 Month	Presence or absence of gingival bleeding on gentle probing to determine gingival health

Trial Locations

Locations (1)

College of Dentistry, University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada