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BIOSILITACE AS A DESENSITIZING AGENTIN HMI
Sponsor: University of Sao Paulo
Summary
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).
Official title: Biosilicate as a Desensitizing Agent in Teeth With Molar Incisor Hypomineralization in Children: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2025-07-30
Completion Date
2025-11-15
Last Updated
2025-07-23
Healthy Volunteers
No
Interventions
Pain Relieving
aim to relieve tooth pain with HMI Biosilicate
topical application
the operator will apply a solution to all the free surfaces of the selected teeth using a microapplicator. The solution will either be 10% Biosilicate® solution, fluoride varnish (Duraphat®), or distilled water . All products will be removed from their original containers and placed in identical 10ml plastic bottles, white and standardized. The different products will be applied equally for 15 seconds according to the application protocol.
Locations (2)
Faculdade de Odontologia de Ribeirão Preto FORP USP
Ribeirão Preto, São Paulo, Brazil
Faculdade de Odontologia de Ribeirão Preto FORP USP
Ribeirão Preto, São Paulo, Brazil