Chronic GingivitisNCT03329105
Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health
A study testing Sea Salt Mouth Rinse and Standardized Oral Health Practices in people with Chronic Gingivitis and Chronic Gingivitis, Plaque Induced, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Gingivitis, Chronic Gingivitis, Plaque Induced
- What is being tested?
- Sea Salt Mouth Rinse and Standardized Oral Health Practices
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2016to 24 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Dentate
- Medically healthy
- No orthodontic bands
- An anticipated ability to attend the two scheduled visits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Dentistry, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5E4
About this study
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.
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.
Read the 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.
- Being tested
- Sea Salt Mouth Rinse, Standardized Oral Health Practices
- Keywords
- Gingival Health, Biofilm Formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sea Salt Mouth RinseOther
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 PracticesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Sea Salt Mouth Rinse | Experimental | Not described Receives: Other: Sea Salt Mouth Rinse; Other: Standardized Oral Health Practices |
| Standardized Oral Health Practices | Active comparator | Not described Receives: Other: Standardized Oral Health Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start7 Nov 2016
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Hoover, University of Saskatchewan
- Investigators
- Jay Hoover, Principal investigator, Professor, College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329105
- Sponsor's protocol ID
- 16-272
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12102700Burt 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.
PubMed 16101377Axelsson 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.
PubMed 2061418Bizarra 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.
PubMed 19659714Litonjua LA, Cabanilla LL, Abbott LJ. Plaque formation and marginal gingivitis associated with restorative materials. Compend Contin Educ Dent. 2011 May;32(4):e69-72.
PubMed 23738894Brecx 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.
PubMed 9643237Jackson 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.
PubMed 9643234
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03329105
- Acronym / sponsor ID
- 16-272
- Keywords
- Gingival Health, Biofilm Formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sea Salt Mouth Rinse | Experimental | Other: Sea Salt Mouth Rinse, Other: Standardized Oral Health Practices |
| Standardized Oral Health Practices | Active comparator | Other: Standardized Oral Health Practices |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Dentate
- Medically healthy
- No orthodontic bands
- An anticipated ability to attend the two scheduled visits
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sea Salt Mouth RinseRinsing 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. | Other | Sea Salt Mouth Rinse |
| Standardized Oral Health PracticesBrushing teeth for two minutes using the modified Bass technique, twice per day with the provided dentifrice, and flossing once daily using the spool method | Other | Sea Salt Mouth Rinse, Standardized Oral Health Practices |
Primary outcome
Turesky modification of Quigley-Hein plaque index
Time frame: 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
Time frame: Baseline and 1 Month
Presence or absence of gingival bleeding on gentle probing to determine gingival health
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Background: PubMed 12102700Albandar 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.
- Background: PubMed 16101377Burt 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.
- Background: PubMed 2061418Axelsson 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.
- Background: PubMed 19659714Bizarra 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.
- Background: PubMed 23738894Litonjua LA, Cabanilla LL, Abbott LJ. Plaque formation and marginal gingivitis associated with restorative materials. Compend Contin Educ Dent. 2011 May;32(4):e69-72.
- Background: PubMed 9643237Brecx 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.
- Background: PubMed 9643234Jackson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Hoover principal investigator
Professor, College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sea Salt Mouth Rinse and Standardized Oral Health Practices in people with Chronic Gingivitis and Chronic Gingivitis, Plaque Induced, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turesky modification of Quigley-Hein plaque index (time frame: Change from Baseline at 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329105, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.