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NCT03049761 Clinical Trial

Water Flosser vs String Floss vs Manual Toothbrush Safety

Soft Tissue Injuries Clinical Trial

Official title:
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03049761
Other study ID # 2017-WP-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 9, 2017
Est. completion date February 23, 2017

Study information
Verified date February 2017
Source All Sum Research Center Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date February 23, 2017
Est. primary completion date February 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Water Flosser
Power interdental cleaner
• String Floss
Mechanical interdental cleaner
• Manual Toothbrush
ADA standard soft bristle toothbrush

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
All Sum Research Center Ltd. Water Pik, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Attachment Levels Measurement from the junction Epithelium to the cemento enamel junction 6 weeks
Secondary Probing pocket depth Measurement from the junction Epithelium to the free gingival margin 6 weeks
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