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

NCT05597956 | Completed

• 1 other identifier: O00017836e2200003229
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• aesthetic change of opacities

  Between five and six months

Study Arms (3)

white defects

EXPERIMENTAL

Evaluate the infiltration of the defects.

Procedure: yellow defects; Procedure: brown defects

yellow defects

EXPERIMENTAL

Evaluate the infiltration of the defects.

Procedure: white defects; Procedure: brown defects

Brown defects

EXPERIMENTAL

Evaluate the infiltration of the defects.

Procedure: white defects; Procedure: yellow defects

Interventions

white defects 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; yellow defects

yellow defects 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; white defects

brown defects 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".

white defects; yellow defects

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universitat de València

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 41597140 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 28, 2022
• Study Start: September 19, 2023
• Primary Completion: September 12, 2024
• Study Completion: December 6, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)