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

Primary Purpose

Chronic Gingivitis, Chronic Gingivitis, Plaque Induced

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sea Salt Mouth Rinse
Standardized Oral Health Practices
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Gingivitis focused on measuring Gingival Health, Biofilm Formation

Eligibility Criteria

20 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • College of Dentistry, University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sea Salt Mouth Rinse

Standardized Oral Health Practices

Arm Description

Outcomes

Primary Outcome Measures

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.
Presence or absence of gingival bleeding
Presence or absence of gingival bleeding on gentle probing to determine gingival health

Secondary Outcome Measures

Full Information

First Posted
October 17, 2017
Last Updated
October 30, 2017
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT03329105
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
August 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Gingivitis, Chronic Gingivitis, Plaque Induced
Keywords
Gingival Health, Biofilm Formation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sea Salt Mouth Rinse
Arm Type
Experimental
Arm Title
Standardized Oral Health Practices
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Sea Salt Mouth Rinse
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standardized Oral Health Practices
Intervention Description
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
Primary Outcome Measure Information:
Title
Turesky modification of Quigley-Hein plaque index
Description
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.
Time Frame
Change from Baseline at 1 Month
Title
Presence or absence of gingival bleeding
Description
Presence or absence of gingival bleeding on gentle probing to determine gingival health
Time Frame
Baseline and 1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Hoover
Organizational Affiliation
Professor, College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry, University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5E4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12102700
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.
Results Reference
background
PubMed Identifier
16101377
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.
Results Reference
background
PubMed Identifier
2061418
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.
Results Reference
background
PubMed Identifier
19659714
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.
Results Reference
background
PubMed Identifier
23738894
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.
Results Reference
background
PubMed Identifier
9643237
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.
Results Reference
background
PubMed Identifier
9643234
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.
Results Reference
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Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health

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