NCT01994278

Brief Summary

The aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. The hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless methods in conjunction with flossing.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

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

First Submitted

Initial submission to the registry

July 31, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

July 31, 2012

Last Update Submit

November 19, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Silness Gingival index

    using a periodontal probe gently between the tooth and gum

    June 2013

Study Arms (1)

Tooth brush

EXPERIMENTAL

Periclean is a soft rubber gentle toothbrush

Device: Peri Clean

Interventions

Tooth brush

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age
  • healthy gingiva

You may not qualify if:

  • less than 18 yrs old
  • patients with braces
  • decisionally impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

November 25, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-04