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

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.

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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