Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681135

Enrollment

118

Registered

2008-05-21

Start date

2008-04-30

Completion date

2011-04-30

Last updated

2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque, Gingivitis

Keywords

orthodontics, toothbrush, interdental brush, oral hygiene

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.

Interventions

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

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

DEVICEmanual 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

DEVICEmanual toothbrush (elmex® Inter X medium toothbrush)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

11 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Plaque Indices	every 4 weeks for 3 months
Gingival Indices	every 4 weeks for 3 months

Secondary

Measure	Time frame
Periodontal parameters	every 4 weeks
Microbiological parameters	every 4 weeks
Molecularbiological parameters	every 4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026