Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities

Molar Incisor Hypomineralization Clinical Trial

Official title:

Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05597956
• Other study ID #: O00017836e2200003229
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

Inclusion Criteria:

. 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anterior Teeth
• Children, Adult
• Dental Diseases
• Molar Incisor Hypomineralization
• Stomatognathic Diseases

Intervention

Procedure:
• 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".
• 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".
• 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".

Locations

Country	Name	City	State
Spain	Universitat de València	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Between five and six months
Primary	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.	Between five and six months
Secondary	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.	Between five and six months