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

Study Overview
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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.

Official Title
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Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health in a Group of Young Adults: A Pilot Study.

Conditions
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Chronic Gingivitis, Chronic Gingivitis, Plaque Induced

Intervention / Treatment
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* Other: Sea Salt Mouth Rinse
* Other: Standardized Oral Health Practices


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sea Salt Mouth Rinse<br> | Other: Sea Salt Mouth Rinse<br>* 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.<br>Other: Standardized Oral Health Practices<br>* 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<br>|
| Active Comparator: Standardized Oral Health Practices<br> | Other: Standardized Oral Health Practices<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival Health, Biofilm Formation