Molar Incisor Hypomineralization
Conditions
Interventions
This project is a triple-blind randomized clinical trial. A researcher not involved in the study will perform the randomization using a non-probability sequential method. The blinding will be achieved
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged 6-12 years; with fully erupted permanent central and lateral incisors; with MIH lesions of any severity level diagnosed by a trained dentist according to the criteria established by Ghanim et al. (2017).
Exclusion criteria
Exclusion criteria: Children with syndromes; children undergoing orthodontic treatment with fixed appliances; previously restored or treated permanent incisors; presence of other enamel defects such as dental fluorosis/hypoplasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate mineral gain using the Quantitative Light-Induced Fluorescence (QLF) technique. The analysis will be comparative, comparing images from the same patients before the intervention, 5 minutes after, 1 hour after, and after 45 days of daily toothpaste use. The parameters will be changes in fluorescence (?F, %) and lesion area (mm²), which indicate and quantify mineral gain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dental sensitivity will be assessed using a Visual Analog Scale (VAS). The VAS consists of a horizontal line marked from 0 to 10 centimeters on an A4 paper sheet, where the individual marks their level of pain. The scale has 10 points, with point 0 meaning "No pain" and point 10 meaning "Severe pain." Between points 1 and 2, the pain is classified as "mild pain." Between 3 and 7, it's "moderate pain," and between 8 and 10, "intense pain." Simultaneously, the Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used. This behavioral scale is reliable because it is well-understood by healthcare professionals and has been validated for this purpose. The FLACC scale is completed by a healthcare professional, who evaluates the child's behavioral changes based on the categories of "Face," "Legs," "Activity," "Cry," and "Consolability." Each category is scored from 0, 1, or 2 points, where 0 represents the most comfortable situation and 2 indicates the presence of pain. The scale has a maximum score of 10 points and provides details on the signs for each score per category.;The aesthetics of the affected teeth will be evaluated before the intervention and after 45 days using the Child's and Parent's Questionnaire about Teeth Appearance. This is a validated translation into Brazilian Portuguese of the original English instrument, and it will be completed by both the children and their guardians.;Adverse effects reported by the patients and/or guardians will be recorded and evaluated at the final follow-up, after 45 days. Finally, they will be asked about the acceptability of the toothpaste. | — |
Countries
Brazil
Contacts
Public ContactLuciana;Paulo dos Santos;Martins-Júnior
Universidade Federal de Minas Gerais;Universidade Federal de Minas Gerais
Outcome results
None listed