Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth

Plaque Control Clinical Trial

Official title:

Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994278
• Other study ID #: 12-038A
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: November 19, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Peri-Swab, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 yrs of age

• healthy gingiva

Exclusion Criteria:

• less than 18 yrs old

• patients with braces

• decisionally impaired

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Plaque Control

Intervention

Device:
• Peri Clean

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peri-Swab, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Silness Gingival index	using a periodontal probe gently between the tooth and gum	June 2013	No