Tooth; Lesion, White Spot LesionsPhase 4NCT01329731
Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients
A Phase 4 study testing elmex® gelée in people with Tooth; Lesion, White Spot Lesions, run by Gaba International AG at 1 site in Germany.
Trial summary
The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Tooth; Lesion, White Spot Lesions
- What is being tested?
- elmex® gelée
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Oct 2013
- 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 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- Healthy volunteers (≥11 years) scheduled for bracket removal
- ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding
Who cannot join
- Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study
- Known hypersensitivity or allergy to placebo gel ingredients
- Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis
- Any illness/condition potentially affecting the study outcome at investigator's discretion
- Known pregnancy or breast feeding during the course of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Poliklinik für Kieferorthopädie, Justus-Liebig-Universität Giessen
Giessen, D-35392
About this study
Official title: White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months
The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.
- Conditions
- Tooth; Lesion, White Spot Lesions
- Being tested
- elmex® gelée, negative control (placebo)
- Keywords
- white spot lesion, initial caries, fluoride, amine fluoride, orthodontics, remineralization, brackets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elmex® geléeDrug
Also called elmex® gel
1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical
negative control (placebo)Drug
0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical
| Study group | Role | What they receive |
|---|---|---|
| Test | Active comparator | 1.25% fluoride (elmex® gelée) Receives: Drug: elmex® gelée |
| Control | Placebo comparator | 0% fluoride (negative control) Receives: Drug: negative control (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSL-size change
Changes in size of white spot lesions (WSL) at 12 weeks
Measured: 12 weeks
Secondary outcomes (7)
WSL-size change
Changes in size of WSL over study time
Measured: Baseline up to 24 weeks
WSL-brightness change
Changes in WSL brightness value (%)
Measured: Baseline up to 24 weeks
WSL index on all upper front teeth
Modified white spot lesion index (Gorelick et al. 1982):
0: no white spot formation
- slight white spot formation, thin rim
- excessive white spot formation, thicker bands
- white spot formation with cavitation
Measured: Baseline up to 24 weeks
Caries activity
Caries activity index (LAA) according to the ICDAS II (Ekstrand et al. 2007)
Measured: Baseline up to 24 weeks
Plaque index (Silness and Löe 1964)on all upper front teeth
The grades will be assessed visually on all upper front teeth using a standard dental probe.
(0) no plaque on inspection and probing
- thin plaque film on gingival margin, detectable only on probing
- moderate plaque film along the gingival margin, visually detectable even without probing
- a lot of plaque along the gingival margin, filling the interdental spaces
Measured: Baseline up to 24 weeks
Gingival bleeding index on all upper front teeth
Gingival bleeding index (Ainamo and Bay 1975). The following scores will be used:
(0) no bleeding
(1) bleeding occurs
Measured: Baseline up to 24 weeks
DMFT index: Dental health of all teeth
DMFT index according to Klein et al. (1938): Dental health of all teeth will be assessed with respect to decay (D), missing (M) or filling (F). The DMFT-Index will be calculated.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth; Lesion, White Spot LesionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaba International AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PD Dr. Christian Heumann
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329731
- Sponsor's protocol ID
- GASAS-1002X
- Other IDs
- 2010-020538-24
- Status last verified
- May 2011
- First submitted
- 1 Apr 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part II: clinical data evaluation. Eur J Orthod. 2017 Apr 1;39(2):144-152. doi: 10.1093/ejo/cjw061.
PubMed 27702807Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation. Eur J Orthod. 2017 Apr 1;39(2):134-143. doi: 10.1093/ejo/cjw060.
PubMed 27702806
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months
- ClinicalTrials.gov ID
- NCT01329731
- Acronym / sponsor ID
- GASAS-1002X
- Conditions
- Tooth; Lesion, White Spot Lesions
- Keywords
- white spot lesion, initial caries, fluoride, amine fluoride, orthodontics, remineralization, brackets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gaba International AGIndustry (pharma, biotech, devices)
- Collaborators
- PD Dr. Christian Heumann
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Apr 2011 (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 aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Active comparator | Drug: elmex® gelée1.25% fluoride (elmex® gelée) |
| Control | Placebo comparator | Drug: negative control (placebo)0% fluoride (negative control) |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Healthy volunteers (≥11 years) scheduled for bracket removal
- ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding
Key exclusion criteria (5 listed)
- Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study
- Known hypersensitivity or allergy to placebo gel ingredients
- Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis
- Any illness/condition potentially affecting the study outcome at investigator's discretion
- Known pregnancy or breast feeding during the course of the study
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® geléeAlso: elmex® gel1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical | Drug | Test |
| negative control (placebo)0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical | Drug | Control |
Primary outcome
WSL-size change
Time frame: 12 weeks
Changes in size of white spot lesions (WSL) at 12 weeks
7 secondary outcomes
WSL-size change
Time frame: Baseline up to 24 weeks
WSL-brightness change
Time frame: Baseline up to 24 weeks
WSL index on all upper front teeth
Time frame: Baseline up to 24 weeks
Caries activity
Time frame: Baseline up to 24 weeks
Plaque index (Silness and Löe 1964)on all upper front teeth
Time frame: Baseline up to 24 weeks
Gingival bleeding index on all upper front teeth
Time frame: Baseline up to 24 weeks
DMFT index: Dental health of all teeth
Time frame: Baseline, 24 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 11 Dec 2013.
- Derived from this study: PubMed 27702807Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part II: clinical data evaluation. Eur J Orthod. 2017 Apr 1;39(2):144-152. doi: 10.1093/ejo/cjw061.
- Derived from this study: PubMed 27702806Bock NC, Seibold L, Heumann C, Gnandt E, Roder M, Ruf S. Changes in white spot lesions following post-orthodontic weekly application of 1.25 per cent fluoride gel over 6 months-a randomized placebo-controlled clinical trial. Part I: photographic data evaluation. Eur J Orthod. 2017 Apr 1;39(2):134-143. doi: 10.1093/ejo/cjw060.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing elmex® gelée in people with Tooth; Lesion, White Spot Lesions, run by Gaba International AG 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 5 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 11 Dec 2013. 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. Some participants in this study may receive a placebo. 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?
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?
WSL-size change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329731, which also lists 2 linked publications.
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 11 Dec 2013.