Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients

February 21, 2012 updated by: Sebastian Zingler

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Department of Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
  • Philips Sonicare® FlexCare
EXPERIMENTAL: 2
toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
  • elmex® Inter X medium toothbrush / interdental brush Curaprox®
EXPERIMENTAL: 3
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
  • elmex® Inter X medium toothbrush
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Other Names:
  • elmex® Inter X medium toothbrush
ACTIVE_COMPARATOR: 4
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
  • elmex® Inter X medium toothbrush
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Other Names:
  • elmex® Inter X medium toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plaque Indices
Time Frame: every 4 weeks for 3 months
every 4 weeks for 3 months
Gingival Indices
Time Frame: every 4 weeks for 3 months
every 4 weeks for 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Periodontal parameters
Time Frame: every 4 weeks
every 4 weeks
Microbiological parameters
Time Frame: every 4 weeks
every 4 weeks
Molecularbiological parameters
Time Frame: every 4 weeks
every 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Christopher J. Lux, Professor, Department of Orthodontics, University of Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (ESTIMATE)

May 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingivitis

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

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