NCT04017507

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,145

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

January 8, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

July 10, 2019

Last Update Submit

August 13, 2019

Conditions

GingivitisPlaque

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, Papillary bleeding index or Mazza gingival index).

    Up to 12 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 12 weeks

Study Arms (3)

Oscillating-rotating electric toothbrush

Twice daily brushing

Device: Oscillating-rotating electric toothbrush

Side-to-side electric toothbrush

Twice daily brushing

Device: Side-to-side 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
Side-to-side electric toothbrushDEVICE

Side-to-side electric toothbrush used twice daily

Side-to-side electric toothbrush
Manual toothbrushDEVICE

Manual toothbrush used twice daily

Manual toothbrush

Eligibility Criteria

Age18 Years+
Sexall
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 P&G Investigation Clinical Sites

Cincinnati, Ohio, 45040, United States

Location

MeSH Terms

Conditions

GingivitisPlaque, Amyloid

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

January 8, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

US(1)