NCT00877019

Brief Summary

Aim: The study was designed to test the time dependent efficacy in plaque removal of four toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B) brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D) and. Materials and Methods: The study was a single-blind, randomized clinical timer study consisting of four identical experiments testing each brush in one quadrant. The distribution of the quadrants and brushes was randomized so that always all brushes were used within one participant. The teeth were brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was done after each time interval blinded on six sites per tooth by a separate investigator. Ninety subjects participated in the study and received a professional prophylaxis prior to the experiment. They were requested to refrain from brushing their teeth for 48 hours prior to the experiment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

April 6, 2009

Last Update Submit

December 10, 2020

Conditions

Keywords

sonic brushestime effectivenessbrush head designADA-toothbrushprofessional brushingtime dependenceefficacytoothbrush

Interventions

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • at least 24 evaluable teeth in the mouth

You may not qualify if:

  • systemic disease
  • regular drugs or actual antibiotics
  • orthodontic banding or retention wires
  • oral lesions or sites with a probing pocket depth X5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

December 14, 2020

Record last verified: 2020-12