Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

NCT00681135 | Completed

• 1 other identifier: ZKL-08-MHW
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Plaque; Gingivitis

Keywords

orthodontics; toothbrush; interdental brush; oral hygiene

Outcome Measures

Primary Outcomes (2)

• Plaque Indices

  every 4 weeks for 3 months

• Gingival Indices

  every 4 weeks for 3 months

Secondary Outcomes (3)

• Periodontal parameters

  every 4 weeks

• Microbiological parameters

  every 4 weeks

• Molecularbiological parameters

  every 4 weeks

Study Arms (4)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

EXPERIMENTAL

Device: manual toothbrush (elmex® Inter X medium toothbrush)

4

ACTIVE COMPARATOR

Device: manual toothbrush (elmex® Inter X medium toothbrush)

Interventions

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

Also known as: Philips Sonicare® FlexCare

1

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

Also known as: elmex® Inter X medium toothbrush / interdental brush Curaprox®

2

manual toothbrush (elmex® Inter X medium toothbrush) DEVICE

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

Also known as: elmex® Inter X medium toothbrush

3

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• presence of caries lesion
• antibiotic therapy within the previous 6 months
• diagnosis of early onset periodontitis

Sponsors & Collaborators

• Sebastian Zingler: lead

Study Sites (1)

Department of Orthodontics

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Christopher J. Lux, Professor

  Department of Orthodontics, University of Heidelberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. dent. Sebastian Zingler

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

DE (1)