Dental PlaqueNCT00681135
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
A study testing sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04), manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®) and manual toothbrush (elmex® Inter X medium toothbrush) in people with Dental Plaque and Gingivitis, run by Sebastian Zingler at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Dental Plaque, Gingivitis
- What is being tested?
- sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04), manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®) and manual toothbrush (elmex® Inter X medium toothbrush)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- no systemic diseases
- orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
- informed consent
Who cannot join
- presence of caries lesion
- antibiotic therapy within the previous 6 months
- diagnosis of early onset periodontitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dental Plaque, Gingivitis
- Being tested
- sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04), manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®), manual toothbrush (elmex® Inter X medium toothbrush)
- Keywords
- orthodontics, toothbrush, interdental brush, oral hygiene
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)Device
Also called Philips Sonicare® FlexCare
toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)Device
Also called 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
manual toothbrush (elmex® Inter X medium toothbrush)Device
Also called elmex® Inter X medium toothbrush
toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets
manual toothbrush (elmex® Inter X medium toothbrush)Device
Also called elmex® Inter X medium toothbrush
toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04) |
| 2 | Experimental | Not described Receives: Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®) |
| 3 | Experimental | Not described Receives: Device: manual toothbrush (elmex® Inter X medium toothbrush) |
| 4 | Active comparator | Not described Receives: Device: manual toothbrush (elmex® Inter X medium toothbrush) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Indices
Measured: every 4 weeks for 3 months
Gingival Indices
Measured: every 4 weeks for 3 months
Secondary outcomes (3)
Periodontal parameters
Measured: every 4 weeks
Microbiological parameters
Measured: every 4 weeks
Molecularbiological parameters
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebastian Zingler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sebastian Zingler, University of Jena
- Investigators
- Christopher J. Lux, Professor, Study chair, Department of Orthodontics, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681135
- Sponsor's protocol ID
- ZKL-08-MHW
- Status last verified
- Feb 2012
- First submitted
- 16 May 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols
- ClinicalTrials.gov ID
- NCT00681135
- Acronym / sponsor ID
- ZKL-08-MHW
- Conditions
- Dental Plaque, Gingivitis
- Keywords
- orthodontics, toothbrush, interdental brush, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Sebastian ZinglerUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04) |
| 2 | Experimental | Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®) |
| 3 | Experimental | Device: manual toothbrush (elmex® Inter X medium toothbrush) |
| 4 | Active comparator | Device: manual toothbrush (elmex® Inter X medium toothbrush) |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- no systemic diseases
- orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)
- informed consent
Key exclusion criteria (3 listed)
- presence of caries lesion
- antibiotic therapy within the previous 6 months
- diagnosis of early onset periodontitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)Also: Philips Sonicare® FlexCaretoothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets | Device | 1 |
| manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)Also: 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 | Device | 2 |
| manual toothbrush (elmex® Inter X medium toothbrush)Also: elmex® Inter X medium toothbrushtoothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets | Device | 3 |
| manual toothbrush (elmex® Inter X medium toothbrush)Also: elmex® Inter X medium toothbrushtoothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets | Device | 4 |
Primary outcome
Plaque Indices
Time frame: every 4 weeks for 3 months
Gingival Indices
Time frame: every 4 weeks for 3 months
3 secondary outcomes
Periodontal parameters
Time frame: every 4 weeks
Microbiological parameters
Time frame: every 4 weeks
Molecularbiological parameters
Time frame: every 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J. Lux, Professor study chair
Department of Orthodontics, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04), manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®) and manual toothbrush (elmex® Inter X medium toothbrush) in people with Dental Plaque and Gingivitis, run by Sebastian Zingler at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Indices (time frame: every 4 weeks for 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.