CompletedNot Applicable

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

Spain110 participantsStarted 2023-09-19

Plain-language 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.

Who can participate

Age range

9 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the color of opacities

Timeframe: Between five and six months

Change in the density of opacities

Timeframe: Between five and six months

Trial details

NCT IDNCT05597956

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-12

View on ClinicalTrials.gov More Children, Adult trials