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Water Flosser vs String Floss vs Manual Toothbrush Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03049761
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : January 10, 2019
Water Pik, Inc.
Information provided by (Responsible Party):
All Sum Research Center Ltd.

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

Condition or disease Intervention/treatment Phase
Soft Tissue Injuries Device: Water Flosser Device: String Floss Device: Manual Toothbrush Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Active Comparator: Water Flosser
Power interdental Cleaning Device
Device: Water Flosser
Power interdental cleaner

Active Comparator: String floss
Manual interdental cleaning device
Device: String Floss
Mechanical interdental cleaner

Active Comparator: Manual Toothbrush
ADA standard manual toothbrush
Device: Manual Toothbrush
ADA standard soft bristle toothbrush

Primary Outcome Measures :
  1. Clinical Attachment Levels [ Time Frame: 6 weeks ]
    Measurement from the junction Epithelium to the cemento enamel junction

Secondary Outcome Measures :
  1. Probing pocket depth [ Time Frame: 6 weeks ]
    Measurement from the junction Epithelium to the free gingival margin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: All Sum Research Center Ltd. Identifier: NCT03049761    
Other Study ID Numbers: 2017-WP-1
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Soft Tissue Injuries
Wounds and Injuries