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

Not Applicable

Completed

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

• Registration Number: NCT05597956
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Study Start: 2023-09-19
• Primary Completion: 2024-09-12
• Study Completion: 2024-12-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in the color of opacities	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	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.

Secondary Outcome Measures

Name	Time	Method
aesthetic change of opacities	Between five and six months	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.

Trial Locations

Locations (1)

Universitat de València; 🇪🇸 Valencia, Spain