Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681135
• Other study ID #: ZKL-08-MHW
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: February 21, 2012
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

Intervention

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
• 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
• manual toothbrush (elmex® Inter X medium toothbrush)
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
• manual toothbrush (elmex® Inter X medium toothbrush)
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets

Locations

Country	Name	City	State
Germany	Department of Orthodontics	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Sebastian Zingler

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Indices		every 4 weeks for 3 months	No
Primary	Gingival Indices		every 4 weeks for 3 months	No
Secondary	Periodontal parameters		every 4 weeks	No
Secondary	Microbiological parameters		every 4 weeks	No
Secondary	Molecularbiological parameters		every 4 weeks	No