Water Flosser vs String Floss vs Manual Toothbrush Safety

NCT ID: NCT03049761

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2017-02-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Soft Tissue Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Water Flosser

Power interdental Cleaning Device

Group Type ACTIVE_COMPARATOR

Water Flosser

Intervention Type DEVICE

Power interdental cleaner

String floss

Manual interdental cleaning device

Group Type ACTIVE_COMPARATOR

String Floss

Intervention Type DEVICE

Mechanical interdental cleaner

Manual Toothbrush

ADA standard manual toothbrush

Group Type ACTIVE_COMPARATOR

Manual Toothbrush

Intervention Type DEVICE

ADA standard soft bristle toothbrush

Interventions

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Water Flosser

Power interdental cleaner

Intervention Type DEVICE

String Floss

Mechanical interdental cleaner

Intervention Type DEVICE

Manual Toothbrush

ADA standard soft bristle toothbrush

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Water Pik, Inc.

INDUSTRY

Sponsor Role collaborator

All Sum Research Center Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2017-WP-1

Identifier Type: -

Identifier Source: org_study_id

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