- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00681135
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
Status
Completed
Conditions
Intervention / Treatment
- 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)
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:
|
EXPERIMENTAL: 2
|
toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
|
EXPERIMENTAL: 3
|
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Other Names:
|
ACTIVE_COMPARATOR: 4
|
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
Other Names:
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Other Names:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZKL-08-MHW
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
-
Zainab J AbbasCompleted
-
University of SaskatchewanCompletedChronic Gingivitis | Chronic Gingivitis, Plaque InducedCanada
-
Cairo UniversityNot yet recruiting
-
Hospital Universiti Sains MalaysiaRecruitingGingivitis | Plaque Induced GingivitisMalaysia
-
Lander Enterprises, LLCCompletedPlaque Induced GingivitisUnited States
-
University of WashingtonColgate PalmoliveCompleted
-
Tokat Gaziosmanpasa UniversityAbant Izzet Baysal UniversityCompletedPregnancy Gingivitis
-
Maharishi Markendeswar University (Deemed to be...CompletedChronic GingivitisIndia
-
Ain Shams UniversityCompleted
-
IRCCS San RaffaeleUnknown
Clinical Trials on sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)
-
University Hospital, Strasbourg, FranceRecruiting
-
Claude Bernard UniversityElsan; University of NancyEnrolling by invitation