Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Plaque, Gingivitis

Intervention / Treatment
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* 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)
* Device: manual toothbrush (elmex® Inter X medium toothbrush)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)<br>* toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets<br>* Other names: Philips Sonicare® FlexCare;|
| Experimental: 2<br> | Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)<br>* toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets<br>* Other names: elmex® Inter X medium toothbrush / interdental brush Curaprox®;|
| Experimental: 3<br> | Device: manual toothbrush (elmex® Inter X medium toothbrush)<br>* toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets<br>* Other names: elmex® Inter X medium toothbrush;|
| Active Comparator: 4<br> | Device: manual toothbrush (elmex® Inter X medium toothbrush)<br>* toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets<br>* Other names: elmex® Inter X medium toothbrush;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Indices |  | every 4 weeks for 3 months | 
| Gingival Indices |  | every 4 weeks for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal parameters |  | every 4 weeks | 
| Microbiological parameters |  | every 4 weeks | 
| Molecularbiological parameters |  | every 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthodontics, toothbrush, interdental brush, oral hygiene