Children, AdultNCT05597956
Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities
A study testing white defects, yellow defects and brown defects in people with Children, Adult and Molar Incisor Hypomineralization, run by University of Valencia at 1 site in Spain.
Trial summary
Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Children, Adult, Molar Incisor Hypomineralization, Dental Diseases
- What is being tested?
- white defects, yellow defects and brown defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2023to 6 Dec 2024
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- . Pediatric patients, aged between 9 and 16 years.
- Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors.
- Patients who present at least one opacity in the central incisors.
- Go to the dental clinic for revision or treatment of the University of Valencia.
Who cannot join
- Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients
Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. In hypomineralized enamel, light rays encounter multiple interfaces between organic and mineral fluids, with different refractive indices. At each interface, the light is deflected and reflected, producing an overexposed "optical labyrinth" that is perceived as a yellow, white, or brown stain.
The term "infiltration" has been modified and developed commercially in Germany for the treatment of non-cavitated caries on smooth and proximal surfaces, in which the porosities of the enamel lesion are infiltrated with a low-viscosity resin, thus creating a barrier of diffusion, without the need for any type of additional material on the tooth surface.
Read more
An added positive effect of infiltration with the queens is that the enamel lesions lose their whitish appearance when the microporosities are filled, mimicking the area of the lesion with the remaining healthy enamel. This effect is what has led clinicians to adapt this treatment for the management of enamel defects.
Given the growing interest in the treatment of opacities in the anterior sector, due to the demanding contemporary aesthetic requirements, and the increased acceptance of minimally invasive therapies, the need has been seen to seek greater predictability for the treatment of defects. of conservative enamel from an early age and offer effective therapeutic alternatives.
- Conditions
- Children, Adult, Molar Incisor Hypomineralization, Dental Diseases, Opacity, Anterior Teeth
- Being tested
- white defects, yellow defects, brown defects
- Medical subject headings
- Molar Hypomineralization, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white defectsProcedure or surgery
"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".
yellow defectsProcedure or surgery
"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".
brown defectsProcedure or surgery
"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".
| Study group | Role | What they receive |
|---|---|---|
| white defects | Experimental | Evaluate the infiltration of the defects. Receives: Procedure: yellow defects; Procedure: brown defects |
| yellow defects | Experimental | Evaluate the infiltration of the defects. Receives: Procedure: white defects; Procedure: brown defects |
| Brown defects | Experimental | Evaluate the infiltration of the defects. Receives: Procedure: white defects; Procedure: yellow defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the color of opacities
Measured in color changes of opacities using the CIE L*A*B* system. The color of (coated) objects is visualized and quantified by using the CIELAB color space. The 3-dimensional color space is built-up from three axes that are perpendicular to one another.The L*-axis gives the lightness: a white object has an L* value of 100 and the L* value of a black object is 0. The so-called achromatic colors, the shades of grey, are on the L*-axis.
Chromatic ('real') colors are described by using the two axes in the horizontal plane. The a*-axis is the green-red axis and the b*-axis goes from blue (-b*) to yellow (+b*).its measurement is possible thanks to the spectrophotometer.
Clinical improvement and better visual perception of infiltrated enamel defects
Measured: Between five and six months
Change in the density of opacities
DIAGNOdent is a diagnostic method based on an intermittent red fluorescence laser with a wavelength of 655 nm and 1 mW (milliwatt )that penetrates several millimeters from the tooth surface.
Measured: Between five and six months
Secondary outcomes (1)
aesthetic change of opacities
Satisfaction questionnaire. A post-treatment questionnaire will be passed with questions regarding the satisfaction of the patient and parents. The results will be classified from 0 to 4, with 0 being not at all satisfied and 4 being very satisfied.
Measured: Between five and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start19 Sep 2023
- Primary completion12 Sep 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children, AdultStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Catalá Pizarro, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597956
- Sponsor's protocol ID
- O00017836e2200003229
- Status last verified
- Mar 2025
- First submitted
- 20 Oct 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The project will be carried out by a research team. Where there will be a principal investigator, and a collaborator who will carry out the clinical experimentation part.
Publications
Casana-Ruiz MD, Vello-Ribes MA, Catala-Pizarro M. Resin Infiltration for Anterior Teeth Affected by Molar Incisor Hypomineralization in Children and Adolescents: A Clinical Study of Color Masking, Sensitivity, and Aesthetic Perception: A Prospective Single-Arm Interventional Clinical Study. Children (Basel). 2026 Jan 15;13(1):131. doi: 10.3390/children13010131.
PubMed 41597140
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients
- ClinicalTrials.gov ID
- NCT05597956
- Acronym / sponsor ID
- O00017836e2200003229
- Conditions
- Children, Adult, Molar Incisor Hypomineralization, Dental Diseases, Opacity, Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 28 Oct 2022 (actual)
- 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.
Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. In hypomineralized enamel, light rays encounter multiple interfaces between organic and mineral fluids, with different refractive indices. At each interface, the light is deflected and reflected, producing an overexposed "optical labyrinth" that is perceived as a yellow, white, or brown stain.
The term "infiltration" has been modified and developed commercially in Germany for the treatment of non-cavitated caries on smooth and proximal surfaces, in which the porosities of the enamel lesion are infiltrated with a low-viscosity resin, thus creating a barrier of diffusion, without the need for any type of additional material on the tooth surface.
An added positive effect of infiltration with the queens is that the enamel lesions lose their whitish appearance when the microporosities are filled, mimicking the area of the lesion with the remaining healthy enamel. This effect is what has led clinicians to adapt this treatment for the management of enamel defects.
Given the growing interest in the treatment of opacities in the anterior sector, due to the demanding contemporary aesthetic requirements, and the increased acceptance of minimally invasive therapies, the need has been seen to seek greater predictability for the treatment of defects. of conservative enamel from an early age and offer effective therapeutic alternatives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| white defects | Experimental | Procedure: yellow defects, Procedure: brown defectsEvaluate the infiltration of the defects. |
| yellow defects | Experimental | Procedure: white defects, Procedure: brown defectsEvaluate the infiltration of the defects. |
| Brown defects | Experimental | Procedure: white defects, Procedure: yellow defectsEvaluate the infiltration of the defects. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- . Pediatric patients, aged between 9 and 16 years.
- Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors.
- Patients who present at least one opacity in the central incisors.
- Go to the dental clinic for revision or treatment of the University of Valencia.
Key exclusion criteria (1 listed)
- Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.
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 |
|---|---|---|
| white defects"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel". | Procedure or surgery | Brown defects, yellow defects |
| yellow defects"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel". | Procedure or surgery | Brown defects, white defects |
| brown defects"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel". | Procedure or surgery | white defects, yellow defects |
Primary outcome
Change in the color of opacities
Time frame: Between five and six months
Measured in color changes of opacities using the CIE L*A*B* system. The color of (coated) objects is visualized and quantified by using the CIELAB color space. The 3-dimensional color space is built-up from three axes that are perpendicular to one another.The L*-axis gives the lightness: a white object has an L* value of 100 and the L* value of a black object is 0. The so-called achromatic colors, the shades of grey, are on the L*-axis. Chromatic ('real') colors are described by using the two axes in the horizontal plane. The a*-axis is the green-red axis and the b*-axis goes from blue (-b*) to yellow (+b*).its measurement is possible thanks to the spectrophotometer. Clinical improvement and better visual perception of infiltrated enamel defects
Change in the density of opacities
Time frame: Between five and six months
DIAGNOdent is a diagnostic method based on an intermittent red fluorescence laser with a wavelength of 655 nm and 1 mW (milliwatt )that penetrates several millimeters from the tooth surface.
1 secondary outcome
aesthetic change of opacities
Time frame: Between five and six months
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 28 Mar 2025.
- Derived from this study: PubMed 41597140Casana-Ruiz MD, Vello-Ribes MA, Catala-Pizarro M. Resin Infiltration for Anterior Teeth Affected by Molar Incisor Hypomineralization in Children and Adolescents: A Clinical Study of Color Masking, Sensitivity, and Aesthetic Perception: A Prospective Single-Arm Interventional Clinical Study. Children (Basel). 2026 Jan 15;13(1):131. doi: 10.3390/children13010131.
- Individual participant dataSharing planned: No. The project will be carried out by a research team. Where there will be a principal investigator, and a collaborator who will carry out the clinical experimentation part.
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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 study testing white defects, yellow defects and brown defects in people with Children, Adult and Molar Incisor Hypomineralization, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 1 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 28 Mar 2025. 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 Spain. 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?
Change in the color of opacities (time frame: Between five and six 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?
On the ClinicalTrials.gov record for NCT05597956, which also lists 1 linked publication.
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 28 Mar 2025.