Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

NCT ID: NCT00681135

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

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.

Detailed Description

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Conditions

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Dental Plaque Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

2

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

3

Group Type EXPERIMENTAL

manual toothbrush (elmex® Inter X medium toothbrush)

Intervention Type DEVICE

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

4

Group Type ACTIVE_COMPARATOR

manual toothbrush (elmex® Inter X medium toothbrush)

Intervention Type DEVICE

toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets

Interventions

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

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

Intervention Type DEVICE

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

Intervention Type DEVICE

manual toothbrush (elmex® Inter X medium toothbrush)

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

Intervention Type DEVICE

manual toothbrush (elmex® Inter X medium toothbrush)

toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets

Intervention Type DEVICE

Other Intervention Names

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Philips Sonicare® FlexCare elmex® Inter X medium toothbrush / interdental brush Curaprox® elmex® Inter X medium toothbrush elmex® Inter X medium toothbrush

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
Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sebastian Zingler

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Zingler

Dr. med. dent. Sebastian Zingler

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christopher J. Lux, Professor

Role: STUDY_CHAIR

Department of Orthodontics, University of Heidelberg

Locations

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Department of Orthodontics

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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ZKL-08-MHW

Identifier Type: -

Identifier Source: org_study_id

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