FluorosisNCT02925780
12 Month Follow up in Vivo Icon Study on Fluorotic Teeth
A study testing Resin infiltration and Microabrasion in people with Fluorosis and Oral Deseases, run by DMG Dental Material Gesellschaft mbH.
Trial summary
Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Fluorosis, Oral Deseases
- What is being tested?
- Resin infiltration and Microabrasion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2021
- 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Questionable, Very mild, and Mild (Dean's Index) dental fluorosis as well as TF scale grades 1, 2, and 3 of the upper anterior teeth.
- Parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups.
Who cannot join
- Teeth without fluorosis.
- Teeth with hypoplasia.
- Teeth with incipient caries lesions observed at gingival level and differentiated by the Presence of plaque.
- Teeth previously restored or with aesthetic corrective treatments
- Teeth with endodontic treatment.
- Patients with low or questionable hygiene.
Show all 10Show fewer
- Malnourished patients or that have some underlying disease.
- Teeth with less than two thirds of its visible crown.
- Children that have less than six teeth in their oral cavity.
- Allergic reaction to methylmethacrylate.
About this study
Official title: In Vivo Action of Infiltrating Resin Icon® on Fluorosis - a 12 Month Follow up Trial
Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.
Read the detailed description
Dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. Anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. In addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact.
The aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. Resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. This approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies.
This study will be conducted in the provinces of Pichincha and Cotopaxi, Ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the Thylstrup and Fejerskov (TF) scale or questionable, very mild, and mild fluorosis according to Dean's Index will be recruited. In addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 12 months.
- Conditions
- Fluorosis, Oral Deseases
- Being tested
- Resin infiltration, Microabrasion
- Keywords
- Enamel defects, Fluorosis, Icon, Resin infiltration
- Medical subject headings
- Fluoride Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationDevice
Also called Icon (DMG, Germany), Approximal resin infiltration kit
Teeth selected for this group will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, teeth will be isolated with a rubber dam and the labial tooth surface cleaned with non-fluoride prophylactic paste and pumice. After an etching and drying step (to open the lesion surface), Icon will be applied following the manufacturer's instructions and subsequently light cured, followed by polishing.
Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months).
MicroabrasionDevice
Also called Opalustre (Ultradent, USA)
The labial surfaces of teeth selected for this group will be isolated and precleaned. Subsequently, the microabrasive material, Opalustre, will be applied according to the manufacturer's instructions, using a rubber cup at low speed (5 times each for 5 seconds). Between each of the applications the surface is washed by flushing water using a syringe.
Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months).
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration | Experimental | The labial surface of fluorosed teeth (upper front teeth) that are selected for this group will be treated using the resin infiltrant "Icon" (DMG, Germany). This is a minimally invasive treatment to improve the aesthetics by masking the white spots. Receives: Device: Resin infiltration |
| Microabrasion | Active comparator | The labial surface of fluorosed teeth (upper front teeth) that are selected for this group will be treated by microabrasion using the microabrasive material "Opalustre" (Ultradent, USA). This is a minimally invasive treatment to improve the aesthetics by masking the white spots. Receives: Device: Microabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel
Evaluate the action of DMG Icon-infiltrative resin and micro abrasion immediately after application to mask fluorotic teeth by comparison of pre- vs. post-treatment photographs
Measured: immediate after treatment
Secondary outcomes (3)
Surface changes
changes that occur on the surface of the teeth with fluorosis, which have been treated with DMG Icon ® and micro-abrasion assessed via photographs
Measured: 12 month
Clinical characteristics Icon
clinical characteristics of the tooth surfaces that have been treated with DMG Icon ® and micro-abrasion and its relationship to the degree of fluorosis
Measured: 3, 6, 9, 12 month
Efficacy of infiltration to mask fluorotic teeth long-time
Compare the benefit of the infiltrative resin DMG Icon related to micro abrasion Opalustre ULTRADENT as control procedure, focus: stabilisation of masking quantified by photographs
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startDec 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Organisational and regulatory challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluorosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Armas Vega, Principal investigator, Universidad Internacional del Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925780
- Sponsor's protocol ID
- RIAFLUOR
- Status last verified
- Jun 2023
- First submitted
- 28 Sep 2016
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Action of Infiltrating Resin Icon® on Fluorosis - a 12 Month Follow up Trial
- ClinicalTrials.gov ID
- NCT02925780
- Acronym / sponsor ID
- RIAFLUOR
- Conditions
- Fluorosis, Oral Deseases
- Keywords
- Enamel defects, Fluorosis, Icon, Resin infiltration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Organisational and regulatory challenges.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Oct 2016 (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.
Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.
Detailed description
Dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. Anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. In addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact.
The aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. Resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. This approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies.
This study will be conducted in the provinces of Pichincha and Cotopaxi, Ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the Thylstrup and Fejerskov (TF) scale or questionable, very mild, and mild fluorosis according to Dean's Index will be recruited. In addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration | Experimental | Device: Resin infiltrationThe labial surface of fluorosed teeth (upper front teeth) that are selected for this group will be treated using the resin infiltrant "Icon" (DMG, Germany). This is a minimally invasive treatment to improve the aesthetics by masking the white spots. |
| Microabrasion | Active comparator | Device: MicroabrasionThe labial surface of fluorosed teeth (upper front teeth) that are selected for this group will be treated by microabrasion using the microabrasive material "Opalustre" (Ultradent, USA). This is a minimally invasive treatment to improve the aesthetics by masking the white spots. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Questionable, Very mild, and Mild (Dean's Index) dental fluorosis as well as TF scale grades 1, 2, and 3 of the upper anterior teeth.
- Parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups.
Key exclusion criteria (10 listed)
- Teeth without fluorosis.
- Teeth with hypoplasia.
- Teeth with incipient caries lesions observed at gingival level and differentiated by the Presence of plaque.
- Teeth previously restored or with aesthetic corrective treatments
- Teeth with endodontic treatment.
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 |
|---|---|---|
| Resin infiltrationAlso: Icon (DMG, Germany), Approximal resin infiltration kitTeeth selected for this group will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, teeth will be isolated with a rubber dam and the labial tooth surface cleaned with non-fluoride prophylactic paste and pumice. After an etching and drying step (to open the lesion surface), Icon will be applied following the manufacturer's instructions and subsequently light cured, followed by polishing. Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months). | Device | Resin infiltration |
| MicroabrasionAlso: Opalustre (Ultradent, USA)The labial surfaces of teeth selected for this group will be isolated and precleaned. Subsequently, the microabrasive material, Opalustre, will be applied according to the manufacturer's instructions, using a rubber cup at low speed (5 times each for 5 seconds). Between each of the applications the surface is washed by flushing water using a syringe. Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months). | Device | Microabrasion |
Primary outcome
action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel
Time frame: immediate after treatment
Evaluate the action of DMG Icon-infiltrative resin and micro abrasion immediately after application to mask fluorotic teeth by comparison of pre- vs. post-treatment photographs
3 secondary outcomes
Surface changes
Time frame: 12 month
Clinical characteristics Icon
Time frame: 3, 6, 9, 12 month
Efficacy of infiltration to mask fluorotic teeth long-time
Time frame: 12 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Fluorosis
Enrolling by invitation
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
Fluorosis, Dental, Fluorosis
Active, not recruiting
Design of a Multicomponent Intervention to Reduce the Risk of Exposure Fluorine
Fluorosis, Dental, Fluorosis
Not yet recruitingObservational study
Clinical Severity of Dental Fluorosis and Associated Risk Factors Among a Group of Children in Rural Region, Dendera Center in Egypt
Dental Fluorosis
RecruitingObservational study
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Amelogenesis Imperfecta, Dental Fluoroses
Not yet recruitingPhase 4
21% Hydrochloric Acid Based Versus 6.6 % Hydrochloric Based Micro Abrasive Kit in Management of Patients With Mild to Moderate Fluorosis
Enamel Discoloration, Fluorosis, Dental
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.
Ana Armas Vega principal investigator
Universidad Internacional del Ecuador
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration and Microabrasion in people with Fluorosis and Oral Deseases, run by DMG Dental Material Gesellschaft mbH.
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 10 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: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
action of DMG Icon-infiltrative ® resin and micro abrasion to mask fluorotic enamel (time frame: immediate after treatment). 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 Jun 2023.