Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients - Full Text View

Sponsored by:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00681135

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)

Drug Information available for: Elmex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Parallel Assignment
Official Title:	Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols

Further study details as provided by University of Jena:

Primary Outcome Measures:

Quigley-Hein-Index (QHI), Papillen-Blutungs-Index (PBI) [ Time Frame: every 4 weeks for 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Experimental	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
3: Experimental	Device: manual toothbrush (elmex® Inter X medium toothbrush) toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
4: Active Comparator	Device: manual toothbrush (elmex® Inter X medium toothbrush) toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets

Eligibility

Ages Eligible for Study:	11 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

no systemic deseases
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, Thüringen
University of Jena, Department of orthodontics	Recruiting
Jena, Thüringen, Germany, 07740
Contact: Sebastian Zingler 00493641934543 Sebastian.Zingler@med.uni-jena.de
Sub-Investigator: Sebastian Zingler

Sponsors and Collaborators

University of Jena

Investigators

Principal Investigator:

Christopher J. Lux, Professor

Department of Orthodontics, University of Jena

More Information

Responsible Party:	Department of Orthodontics, University of Jena ( Univ.-Prof. Dr. Christopher J. Lux )
Study ID Numbers:	ZKL-08-MHW
Study First Received:	May 16, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00681135
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Jena:

orthodontics
toothbrush
interdental brush
oral hygiene

Study placed in the following topic categories:

Mouth Diseases
Tooth Diseases
Periodontal Diseases
Gingival Diseases

Gingivitis
Stomatognathic Diseases
Dental Plaque

Additional relevant MeSH terms:

Dental Deposits

ClinicalTrials.gov processed this record on January 14, 2009