NCT05594004

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,929

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 21, 2022

Last Update Submit

October 21, 2022

Conditions

GingivitisDental Plaque

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (3)

Oscillating-Rotating electric toothbrush

Twice daily brushing

Device: Oscillating-rotating electric toothbrush

Sonic electric toothbrush

Twice daily brushing

Device: Sonic electric toothbrush

Manual toothbrush

Twice daily brushing

Device: Manual toothbrush

Interventions

Oscillating-rotating electric toothbrushDEVICE

Oscillating-rotating electric toothbrush used twice daily

Oscillating-Rotating electric toothbrush
Sonic electric toothbrushDEVICE

Sonic electric toothbrush used twice daily

Sonic electric toothbrush
Manual toothbrushDEVICE

Manual toothbrush used twice daily

Manual toothbrush

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This meta-analysis includes healthy adult male and females.

Subjects were excluded from this study for the following reasons; * pregnancy, * rampant caries, * severe periodontitis, * at discretionary of the Principal Investigator.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Multiple Study Locations

Cincinnati, Ohio, 45040, United States

Location

MeSH Terms

Conditions

GingivitisDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 26, 2022

Study Start

April 1, 2022

Primary Completion

July 29, 2022

Study Completion

July 29, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

US(1)