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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
History of Changes
  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 Blind (Investigator)
Primary Purpose: Prevention
Official Title: Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols

Resource links provided by NLM:

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 16, 2008
Last Updated: February 21, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 22, 2013