Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastian Zingler, University of Jena
ClinicalTrials.gov Identifier:
NCT00681135
First received: May 16, 2008
Last updated: February 21, 2012
Last verified: February 2012

May 16, 2008
February 21, 2012
April 2008
December 2010   (final data collection date for primary outcome measure)
  • Plaque Indices [ Time Frame: every 4 weeks for 3 months ] [ Designated as safety issue: No ]
  • Gingival Indices [ Time Frame: every 4 weeks for 3 months ] [ Designated as safety issue: No ]
Quigley-Hein-Index (QHI), Papillen-Blutungs-Index (PBI) [ Time Frame: every 4 weeks for 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00681135 on ClinicalTrials.gov Archive Site
  • Periodontal parameters [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • Microbiological parameters [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • Molecularbiological parameters [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Plaque-Index-Bracket (PIB), Approximalraum-Plaque-Index (API), probing pocket depth, bleeding on probing, Caries Risk Test, Matrixmetalloproteinase(MMP8) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Dental Plaque
  • Gingivitis
  • 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
  • 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®
  • 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
  • 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
  • Experimental: 1
    Intervention: Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
  • Experimental: 2
    Intervention: Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)
  • Experimental: 3
    Intervention: Device: manual toothbrush (elmex® Inter X medium toothbrush)
  • Active Comparator: 4
    Intervention: Device: manual toothbrush (elmex® Inter X medium toothbrush)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
April 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
11 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00681135
ZKL-08-MHW
No
Sebastian Zingler, University of Jena
Sebastian Zingler
Not Provided
Study Chair: Christopher J. Lux, Professor Department of Orthodontics, University of Heidelberg
University of Jena
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP