NCT03329105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

October 17, 2017

Last Update Submit

October 30, 2017

Conditions

Chronic GingivitisChronic Gingivitis, Plaque Induced

Keywords

Gingival HealthBiofilm Formation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Sea Salt Mouth Rinse

EXPERIMENTAL
Other: Sea Salt Mouth RinseOther: Standardized Oral Health Practices

Standardized Oral Health Practices

ACTIVE COMPARATOR
Other: Standardized Oral Health Practices

Interventions

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.

Sea Salt Mouth Rinse
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

Sea Salt Mouth RinseStandardized Oral Health Practices

Eligibility Criteria

Age20 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Dentate
  • Medically healthy
  • No orthodontic bands
  • An anticipated ability to attend the two scheduled visits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E4, Canada

Location

Related Publications (7)

  • 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.

    PMID: 12102700BACKGROUND

  • 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.

    PMID: 16101377BACKGROUND

  • 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.

    PMID: 2061418BACKGROUND

  • 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.

    PMID: 19659714BACKGROUND

  • 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.

    PMID: 23738894BACKGROUND

  • 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.

    PMID: 9643237BACKGROUND

  • 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.

    PMID: 9643234BACKGROUND

Study Officials

  • Jay Hoover

    Professor, College of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2017

First Posted

November 1, 2017

Study Start

November 7, 2016

Primary Completion

August 24, 2017

Study Completion

August 24, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)