Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health
NCT ID: NCT02836223
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2016-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Interdental device
Water Flosser
Interdental cleaning device
Water Flosser
Manual Tooth brush
Control
Toothbrush
Control
Manual Tooth brush
Control
Interventions
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Interdental cleaning device
Water Flosser
Manual Tooth brush
Control
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent prior to participation
* Agree to not participate in any other oral/dental products clinical study for the study duration
* Good general health and be a non-smoker
* A minimum of 50% bleeding on probing sites
* A minimum pre-brushing plaque score of 0.6
* A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm
* A minimum of 20 teeth (not including 3rd molars)
* No partial dentures, orthodontic brackets, wires or other appliances
* Agree to refrain from the use of any non-study dental device or oral care product for the study duration
* Agree to return for the scheduled visits and follow study procedures
* Agree to delay dental prophylaxis until study completion
* Have a minimum pre-brushing plaque score of 0.6
* Have a minimum of 1.75 gingivitis score
Exclusion Criteria
* Systemic disease (ex. Diabetes, autoimmune disease)
* Advanced periodontitis
* Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
* Orthodontic appliances or removable partial dentures
* Pregnant at time of study
* Use of antibiotics within 6 months of study
25 Years
70 Years
ALL
Yes
Sponsors
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All Sum Research Center Ltd.
OTHER
Water Pik, Inc.
INDUSTRY
Responsible Party
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Locations
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All Sum Research Center Ltd.
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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16WFVSMTB2016
Identifier Type: -
Identifier Source: org_study_id