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

Sponsor
Procter and Gamble (Industry)
Overall Status
Completed
CT.gov ID
NCT05594004
Collaborator
(none)
2,929
1
3.9
749.2

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Oscillating-rotating electric toothbrush
  • Device: Sonic electric toothbrush
  • Device: Manual toothbrush

Study Design

Study Type:
Observational
Actual Enrollment :
2929 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
A Meta-analysis Comparing Electric and Manual Toothbrushes on Plaque Removal and Gingival Health
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Jul 29, 2022
Actual Study Completion Date :
Jul 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Oscillating-Rotating electric toothbrush

Twice daily brushing

Device: Oscillating-rotating electric toothbrush
Oscillating-rotating electric toothbrush used twice daily

Sonic electric toothbrush

Twice daily brushing

Device: Sonic electric toothbrush
Sonic electric toothbrush used twice daily

Manual toothbrush

Twice daily brushing

Device: Manual toothbrush
Manual toothbrush used twice daily

Outcome Measures

Primary Outcome Measures

  1. Number of Bleeding Sites [Up to 6 months (26 weeks)]

    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).

  2. Dental Plaque Scores [Up to 6 months (26 weeks)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Subjects were excluded from this study for the following reasons;

  • pregnancy,

  • rampant caries,

  • severe periodontitis,

  • at discretionary of the Principal Investigator.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Multiple Study Locations Cincinnati Ohio United States 45040

Sponsors and Collaborators

  • Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT05594004
Other Study ID Numbers:
  • 2022BrushMetaAnalysis
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022