Dental CariesPhase 4NCT00268138
Elmex Gel Efficacy in Preventing White Spot Lesions
A Phase 4 study testing elmex gel in people with Dental Caries, run by Hadassah Medical Organization at 2 sites in 2 countries.
Trial summary
the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- elmex gel
- How many people
- 314 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2006to Dec 2010
- Phase
- Phase 4
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
- written declaration of informed consent
Who cannot join
- known allergy to components of test products
- handicapped patients who have difficulties brushing their teeth
- pathological desquamation changes
- known pregnancy, breast feeding
- eating disorders
- disease that effect dental hard tissue
- participation in another clinical trial either currently or within the lase 30 days
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Charite University
Berlin, D-13353
Paul-Georg Jost-Brinkmann, Prof, ++4930450562532, paul-g.jost-brinkmann@charite.de
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, 91120
Arik tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, Phd, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.
Read the detailed description
314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months.
tooth brushing with product (test product or control) once per week during the entire study.
4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study.
toothbrush and a sandglass will be provided every 6 weeks
- Conditions
- Dental Caries
- Being tested
- elmex gel
- Keywords
- amine fluoride, white spot lesions, qlf
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elmex gelDrug
Also called fluoride
elmex gel once a week
What is being measured
The primary outcome is the main question the study is designed to answer.
time and frequency of visually detected WSL (white spot lesions)
Measured: 3 month
Secondary outcomes (2)
mineral loss according to QLF readings
Measured: 3 month
Frequency and chronoloy of WSL
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startApr 2006
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Gaba International AG
- Investigators
- Meir Redlich, DMD PhD, Principal investigator, Hadassah Medical Center, Dept of OrthodonticsPaul George Jost-Brinkmann, Prof, Principal investigator, Charite - Berlin, Dept of Orthodontics, Center of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268138
- Sponsor's protocol ID
- 123456-HMO-CTIL
- Status last verified
- Dec 2005
- First submitted
- 21 Dec 2005
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
- ClinicalTrials.gov ID
- NCT00268138
- Acronym / sponsor ID
- 123456-HMO-CTIL
- Conditions
- Dental Caries
- Keywords
- amine fluoride, white spot lesions, qlf
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Gaba International AG
- Study start
- Apr 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 22 Dec 2005 (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 objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.
Detailed description
314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months.
tooth brushing with product (test product or control) once per week during the entire study.
4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study.
toothbrush and a sandglass will be provided every 6 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
- written declaration of informed consent
Key exclusion criteria (7 listed)
- known allergy to components of test products
- handicapped patients who have difficulties brushing their teeth
- pathological desquamation changes
- known pregnancy, breast feeding
- eating disorders
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 |
|---|---|---|
| elmex gelAlso: fluorideelmex gel once a week | Drug | – |
Primary outcome
time and frequency of visually detected WSL (white spot lesions)
Time frame: 3 month
2 secondary outcomes
mineral loss according to QLF readings
Time frame: 3 month
Frequency and chronoloy of WSL
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
Meir Redlich, DMD PhD principal investigator
Hadassah Medical Center, Dept of Orthodontics
Paul George Jost-Brinkmann, Prof principal investigator
Charite - Berlin, Dept of Orthodontics, Center of Dentistry
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing elmex gel in people with Dental Caries, run by Hadassah Medical Organization at 2 sites in 2 countries.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Engl, Dr. (++41614156056, a.engl@gaba.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time and frequency of visually detected WSL (white spot lesions) (time frame: 3 month). 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 18 Feb 2009.