NCT05597956

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

Completed NA Last updated 28 March 2025

What this trial tests

NA trial testing white defects in Children, Adult in 110 participants. Completed in 6 December 2024.

Timeline

19 September 2023

Primary endpoint
12 September 2024

6 December 2024

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	19 September 2023
Primary completion	12 September 2024
Estimated completion	6 December 2024
Sites	1 location across Spain

Drugs / interventions tested

• white defects
• yellow defects
• brown defects

Conditions studied

• Children, Adult — all drugs for Children, Adult →
• Molar Incisor Hypomineralization — all drugs for Molar Incisor Hypomineralization →
• Dental Diseases — all drugs for Dental Diseases →
• Opacity — all drugs for Opacity →

Sponsor

University of Valencia

Who can join

Adults 9 to 16, any sex, with Children, Adult or Molar Incisor Hypomineralization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Casaña-Ruiz MD, Vello-Ribes MÁ, Catalá-Pizarro M. · · 2026 · PMID 41597140 · DOI 10.3390/children13010131