Water Flosser vs String Floss vs Manual Toothbrush Safety

Sponsor

All Sum Research Center Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT03049761

Collaborator

Water Pik, Inc. (Industry)

105

Enrollment

Arms

1.5

Actual Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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.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 :

Jan 9, 2017

Actual Primary Completion Date :

Feb 20, 2017

Actual Study Completion Date :

Feb 23, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical Attachment Levels [6 weeks]
Measurement from the junction Epithelium to the cemento enamel junction

Secondary Outcome Measures

Probing pocket depth [6 weeks]
Measurement from the junction Epithelium to the free gingival margin

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

All Sum Research Center Ltd.
Water Pik, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

All Sum Research Center Ltd.

ClinicalTrials.gov Identifier:

NCT03049761

Other Study ID Numbers:

2017-WP-1

First Posted:

Feb 10, 2017

Last Update Posted:

Jan 10, 2019

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Soft Tissue Injuries

Study Results

No Results Posted as of Jan 10, 2019