Time Dependent Professional Toothbrushing Study (timebrush)

This study has been completed.
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00877019
First received: April 6, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Toothbrushing
Device: Sonicare elite medium brush head
Device: Sonicare elite mini brushhead
Device: GABA Elmex sensitive extra soft toothbrush
Device: ADA reference toothbrush

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Time Dependent Professional Toothbrushing Study Comparing Sonicare With Manual Toothbrushes

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Enrollment: 90
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 24 evaluable teeth in the mouth

Exclusion Criteria:

  • systemic disease
  • regular drugs or actual antibiotics
  • orthodontic banding or retention wires
  • oral lesions or sites with a probing pocket depth X5 mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: PD Dr. M. PElka, Dental Clinic 1 - Operative Dentistry and Periodontology, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT00877019     History of Changes
Other Study ID Numbers: 001
Study First Received: April 6, 2009
Last Updated: April 6, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
sonic brushes
time effectiveness
brush head design
ADA-toothbrush
professional brushing
time dependence
efficacy
toothbrush

ClinicalTrials.gov processed this record on August 28, 2014