Clinical trial NCT05597956: Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities
Official title: Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children, Adult
Molar Incisor Hypomineralization
Dental Diseases
Opacity
Anterior Teeth
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 110
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the color of opacities
timeFrame: Between five and six months
measure: Change in the density of opacities
timeFrame: Between five and six months
Secondary outcomes:
measure: aesthetic change of opacities
timeFrame: Between five and six months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
References: