- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03049761
Water Flosser vs String Floss vs Manual Toothbrush Safety
January 9, 2019 updated by: All Sum Research Center Ltd.
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period.
Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written consent prior to participation
- Good general health and non smoker
- Have scorable Ramfjord's teeth
Exclusion Criteria:
- Probing depth >4mm on Ramfjord's teeth
- Moderate to severe gingivitis
- Advanced periodontitis
- Medications that impact soft tissue.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Water Flosser
Power interdental Cleaning Device
|
Power interdental cleaner
|
ACTIVE_COMPARATOR: String floss
Manual interdental cleaning device
|
Mechanical interdental cleaner
|
ACTIVE_COMPARATOR: Manual Toothbrush
ADA standard manual toothbrush
|
ADA standard soft bristle toothbrush
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Attachment Levels
Time Frame: 6 weeks
|
Measurement from the junction Epithelium to the cemento enamel junction
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probing pocket depth
Time Frame: 6 weeks
|
Measurement from the junction Epithelium to the free gingival margin
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 9, 2017
Primary Completion (ACTUAL)
February 20, 2017
Study Completion (ACTUAL)
February 23, 2017
Study Registration Dates
First Submitted
February 7, 2017
First Submitted That Met QC Criteria
February 9, 2017
First Posted (ACTUAL)
February 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-WP-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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