NCT03049761

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
Last Updated

January 10, 2019

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 7, 2017

Last Update Submit

January 9, 2019

Conditions

Soft Tissue Injuries

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Levels

    Measurement from the junction Epithelium to the cemento enamel junction

    6 weeks

Secondary Outcomes (1)

  • Probing pocket depth

    6 weeks

Study Arms (3)

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

Water FlosserDEVICE

Power interdental cleaner

Water Flosser
String FlossDEVICE

Mechanical interdental cleaner

String floss
Manual ToothbrushDEVICE

ADA standard soft bristle toothbrush

Manual Toothbrush

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent prior to participation
  • Good general health and non smoker
  • Have scorable Ramfjord's teeth

You may not qualify if:

  • Probing depth \>4mm on Ramfjord's teeth
  • Moderate to severe gingivitis
  • Advanced periodontitis
  • Medications that impact soft tissue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 10, 2017

Study Start

January 9, 2017

Primary Completion

February 20, 2017

Study Completion

February 23, 2017

Last Updated

January 10, 2019

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share