Water Flosser vs String Floss vs Manual Toothbrush Safety | NCT03049761

Studies
Water Flosser vs String Floss vs Manual Toothbrush Safety

NCT03049761

Sponsor

All Sum Research Center Ltd.

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

105Actual

Phase

Not Applicable

Conditions

Soft Tissue Injuries

Interventions

Water Flosser
String Floss
Manual Toothbrush

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2017Actual

Primary Completion Date

Feb 20, 2017Actual

Completion Date

Feb 23, 2017Actual

First Submitted Date

Feb 7, 2017

First Submission Date that Met QC Criteria

Feb 9, 2017

First Posted Date

Feb 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2019

Last Update Posted Date

Jan 10, 2019Actual

Name	Class
Water Pik, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Water Flosser	Active Comparator	Power interdental Cleaning Device	Device: Water Flosser
String floss	Active Comparator	Manual interdental cleaning device	Device: String Floss
Manual Toothbrush	Active Comparator	ADA standard manual toothbrush	Device: Manual Toothbrush

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Water Flosser	Device	Power interdental cleaner	Water Flosser
String Floss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Attachment Levels	Measurement from the junction Epithelium to the cemento enamel junction	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Probing pocket depth	Measurement from the junction Epithelium to the free gingival margin	6 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided