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Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681135
First Posted: May 21, 2008
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sebastian Zingler, University of Jena
  Purpose
The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.

Condition Intervention
Dental Plaque Gingivitis Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04) Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®) Device: manual toothbrush (elmex® Inter X medium toothbrush)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols

Further study details as provided by Sebastian Zingler, University of Jena:

Primary Outcome Measures:
  • Plaque Indices [ Time Frame: every 4 weeks for 3 months ]
  • Gingival Indices [ Time Frame: every 4 weeks for 3 months ]

Secondary Outcome Measures:
  • Periodontal parameters [ Time Frame: every 4 weeks ]
  • Microbiological parameters [ Time Frame: every 4 weeks ]
  • Molecularbiological parameters [ Time Frame: every 4 weeks ]

Enrollment: 118
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Name: Philips Sonicare® FlexCare
Experimental: 2 Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)
toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Name: elmex® Inter X medium toothbrush / interdental brush Curaprox®
Experimental: 3 Device: manual toothbrush (elmex® Inter X medium toothbrush)
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Name: elmex® Inter X medium toothbrush
Active Comparator: 4 Device: manual toothbrush (elmex® Inter X medium toothbrush)
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Other Name: elmex® Inter X medium toothbrush

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • no systemic diseases
  • orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
  • informed consent

Exclusion Criteria:

  • presence of caries lesion
  • antibiotic therapy within the previous 6 months
  • diagnosis of early onset periodontitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681135


Locations
Germany
Department of Orthodontics
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Sebastian Zingler
Investigators
Study Chair: Christopher J. Lux, Professor Department of Orthodontics, University of Heidelberg
  More Information

Responsible Party: Sebastian Zingler, Dr. med. dent. Sebastian Zingler, University of Jena
ClinicalTrials.gov Identifier: NCT00681135     History of Changes
Other Study ID Numbers: ZKL-08-MHW
First Submitted: May 16, 2008
First Posted: May 21, 2008
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Sebastian Zingler, University of Jena:
orthodontics
toothbrush
interdental brush
oral hygiene

Additional relevant MeSH terms:
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Olaflur
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs