NCT03047759

Brief Summary

Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 21, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
Last Updated

February 9, 2017

Status Verified

August 1, 2016

Enrollment Period

11 days

First QC Date

August 17, 2016

Last Update Submit

February 7, 2017

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • Bleeding upon probing

    Bleeding upon probing

    4 weeks

Secondary Outcomes (2)

  • Gingivitis

    4 weeks

  • Plaque

    4 weeks

Study Arms (2)

Intervention A

ACTIVE COMPARATOR

water flosser

Device: water flosser

Intervention B

ACTIVE COMPARATOR

air floss

Device: air floss

Interventions

water flosserDEVICE

Powered

Intervention A
air flossDEVICE

Powered

Intervention B

Eligibility Criteria

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

You may qualify if:

  • Healthy adult
  • Non smoker
  • Available for 4-weeks
  • Able to provide written informed consent.
  • Minimum of 20 natural teeth.
  • Minimum requirement for plaque, gingivitis and bleeding.

You may not qualify if:

  • Medical condition
  • No antibiotics within 6 months of study start
  • Not on any medication (impact oral health).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

February 9, 2017

Study Start

July 21, 2016

Primary Completion

August 1, 2016

Study Completion

August 19, 2016

Last Updated

February 9, 2017

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share