A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health

Gingivitis Clinical Trial

Official title:

A Meta-analysis Comparing Electric and Manual Toothbrushes on Plaque Removal and Gingival Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594004
• Other study ID #: 2022BrushMetaAnalysis
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: July 29, 2022

Study information

• Verified date: October 2022
• 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 gingivitis- and plaque-reduction efficacy from randomized controlled trials (RCTs) up to six months long evaluating oscillating-rotating, sonic, and manual toothbrushes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2929
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

• Dental Plaque
• Gingivitis

Intervention

Device:
• Oscillating-rotating electric toothbrush
Oscillating-rotating electric toothbrush used twice daily
• Sonic electric toothbrush
Sonic electric toothbrush used twice daily
• Manual toothbrush
Manual toothbrush used twice daily

Locations

Country	Name	City	State
United States	Multiple Study Locations	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, Gingival Bleeding Index (GBI), Papillary bleeding index or Mazza gingival index).	Up to 6 months (26 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 6 months (26 weeks)