The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health

Gingivitis Clinical Trial

Official title:

The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health: A Meta-Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017507
• Other study ID #: 2019BrushMetaAnalysis
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: August 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2145
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Subjects were excluded from this study for the following reasons;

• pregnancy,

• rampant caries,

• severe periodontitis,

• at discretionary of the Principal Investigator.

Related Conditions & MeSH terms

• Gingivitis
• Plaque

Intervention

Device:
• Oscillating-rotating electric toothbrush
Oscillating-rotating electric toothbrush used twice daily
• Side-to-side electric toothbrush
Side-to-side electric toothbrush used twice daily
• Manual toothbrush
Manual toothbrush used twice daily

Locations

Country	Name	City	State
United States	Multiple P&G Investigation Clinical Sites	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Bleeding Sites	Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Papillary bleeding index or Mazza gingival index).	Up to 12 weeks
Primary	Dental Plaque Scores	Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index).	Up to 12 weeks