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Completed

NCT Number: NCT00681135

Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

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.

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Key information

Conditions

Dental Plaque Dental Deposits Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)

Device

toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets

Other names: Philips Sonicare® FlexCare

manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)

Device

toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets

Other names: elmex® Inter X medium toothbrush / interdental brush Curaprox®

manual toothbrush (elmex® Inter X medium toothbrush)

Device

toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets

Other names: elmex® Inter X medium toothbrush

Primary outcomes

  1. Plaque Indices

    Time frame: every 4 weeks for 3 months

  2. Gingival Indices

    Time frame: every 4 weeks for 3 months

Secondary outcomes

  1. Periodontal parameters

    Time frame: every 4 weeks

  2. Microbiological parameters

    Time frame: every 4 weeks

  3. Molecularbiological parameters

    Time frame: every 4 weeks

Sponsors and collaborators

Lead sponsor

Sebastian Zingler

Other

Registry information

Official study title

Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 21, 2008
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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