About this trial
Molar-Incisor Hypomineralization (MIH) is a qualitative enamel defect caused by systemic hypomineralization that affects one to four first permanent molars, and may or may not involve incisors. The clinical repercussions associated with MIH can be characterized by: painful hypersensitivity, post-eruptive fractures, rapid progression of caries lesions in newly erupted first permanent molars, difficulty in achieving effective anesthesia, aesthetic impairments, and patient fear and anxiety. To date, there is no consensus on the best treatment for sensitivity in teeth with MIH, thus managing sensitivity in these teeth remains a significant challenge. The aim of this study is to evaluate the effectiveness of a 10% Biosilicate® solution as a desensitizing agent in MIH teeth in children, compared to Fluoride varnish (Duraphat® Colgate, Brazil). Children aged 6 to 12 years will be selected for this study, with a total of 63 participants diagnosed with MIH, and a sensitivity score ≥2 on the SCASS scale. The children will be randomly divided into two groups (n=21): GI: Duraphat®, GII: Biosilicate®. Interventions will be performed once a week for 4 consecutive weeks, followed by 8 weeks of follow-up. The results will be subjected to statistical tests with a 95% confidence level (α = 0.05).
Eligibility criteria
Qualifiers
Children of both sexes, aged between 6 and 12 years.
Children who have at least one first permanent molar with Molar-Incisor Hypomineralization, showing distinct white or cream opacity (score 21), yellowish or brown opacity (score 22), and/or post-eruptive enamel fracture (score 3), and presence of painful sensitivity when stimulated, with a score of 2 or 3 as evaluated using the SCASS scale.
Children without systemic and/or cognitive impairments.
Disqualifiers
Previous use of desensitizing therapy in the last 6 months;
Use of analgesic and anti-inflammatory medications during the previous 3 days;
Use of orthodontic appliances;
Teeth with extensive restorative procedures, such as stainless steel crowns, which prevent the assessment of painful sensitivity;
Trial design
Treatments tested in this trial
- Pain Relieving
- topical application
Treatment groups
Sponsors and collaborators
University of Sao Paulo
Lead sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator