search
Back to results

Water Flosser vs String Floss vs Manual Toothbrush Safety

Primary Purpose

Soft Tissue Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Water Flosser
String Floss
Manual Toothbrush
Sponsored by
All Sum Research Center Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Soft Tissue Injuries

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Water Flosser

    String floss

    Manual Toothbrush

    Arm Description

    Power interdental Cleaning Device

    Manual interdental cleaning device

    ADA standard manual toothbrush

    Outcomes

    Primary Outcome Measures

    Clinical Attachment Levels
    Measurement from the junction Epithelium to the cemento enamel junction

    Secondary Outcome Measures

    Probing pocket depth
    Measurement from the junction Epithelium to the free gingival margin

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    January 9, 2019
    Sponsor
    All Sum Research Center Ltd.
    Collaborators
    Water Pik, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03049761
    Brief Title
    Water Flosser vs String Floss vs Manual Toothbrush Safety
    Official Title
    Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 9, 2017 (Actual)
    Primary Completion Date
    February 20, 2017 (Actual)
    Study Completion Date
    February 23, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    All Sum Research Center Ltd.
    Collaborators
    Water Pik, Inc.

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Injuries

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Water Flosser
    Arm Type
    Active Comparator
    Arm Description
    Power interdental Cleaning Device
    Arm Title
    String floss
    Arm Type
    Active Comparator
    Arm Description
    Manual interdental cleaning device
    Arm Title
    Manual Toothbrush
    Arm Type
    Active Comparator
    Arm Description
    ADA standard manual toothbrush
    Intervention Type
    Device
    Intervention Name(s)
    Water Flosser
    Intervention Description
    Power interdental cleaner
    Intervention Type
    Device
    Intervention Name(s)
    String Floss
    Intervention Description
    Mechanical interdental cleaner
    Intervention Type
    Device
    Intervention Name(s)
    Manual Toothbrush
    Intervention Description
    ADA standard soft bristle toothbrush
    Primary Outcome Measure Information:
    Title
    Clinical Attachment Levels
    Description
    Measurement from the junction Epithelium to the cemento enamel junction
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    Measurement from the junction Epithelium to the free gingival margin
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Water Flosser vs String Floss vs Manual Toothbrush Safety

    We'll reach out to this number within 24 hrs