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

NCT ID: NCT05597956

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2024-12-06

Brief 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.

Conditions

Children, Adult; Molar Incisor Hypomineralization; Dental Diseases; Opacity; Anterior Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

white defects

Evaluate the infiltration of the defects.

Group Type: EXPERIMENTAL

yellow defects

Intervention Type: PROCEDURE

"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

Intervention Type: PROCEDURE

"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

Evaluate the infiltration of the defects.

Group Type: EXPERIMENTAL

white defects

Intervention Type: PROCEDURE

"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

Intervention Type: PROCEDURE

"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

Evaluate the infiltration of the defects.

Group Type: EXPERIMENTAL

white defects

Intervention Type: PROCEDURE

"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

Intervention Type: PROCEDURE

"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".

Interventions

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".

Intervention Type: PROCEDURE

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".

Intervention Type: PROCEDURE

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".

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Montserrat Catalá Pizarro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat de València

Valencia, , Spain

Countries

Spain

Other Identifiers

O00017836e2200003229

Identifier Type: -

Identifier Source: org_study_id