[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599142":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":72,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":33,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":108,"whyStopped":33,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Biosilicate® 10%","EXPERIMENTAL","Supervised tooth brushing will be performed with fluoride-free toothpaste. Then, the tooth affected by MIH will be cleaned with sterile gauze, isolated with a cotton roll, and subsequently, the operator will apply a solution using a microapplicator to all the free surfaces of the selected teeth. This solution will either be a 10% Biosilicate® solution or fluoride varnish (Duraphat®). 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. Immediately after application, sensitivity tests will be performed using the SCASS and VAS protocols, and will be repeated 1, 2, 4, and 8 weeks after the completion of the treatment. The form for recording the results for each patient is provided in.\n\nBiosilicate (Na₂O-CaO-SiO₂-P₂O₅), a finely particulate glass-ceramic with a high degree of crystallinity (\\~99.5%), exhibiting an",[13,14],"Other: Pain Relieving","Other: topical application",{"label":16,"type":17,"description":18,"interventionNames":19},"Duraphat®","ACTIVE_COMPARATOR","Initially, the child will be instructed not to consume any food or drink for up to 40 minutes after the treatment. Oral hygiene instructions will be given, and a kit with a toothbrush and fluoride toothpaste will be provided. In all groups, the treatment protocols will be applied once a week for 4 consecutive weeks. Supervised tooth brushing will be performed with fluoride-free toothpaste, followed by cleaning the tooth affected by MIH with sterile gauze, isolating it with a cotton roll, and then, 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®). 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.",[13,14],[21,29],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Pain Relieving","aim to relieve tooth pain with HMI Biosilicate",[9,16],[26,27,28],"Pain relieving dentin","Dentin Hypersensitivity","Molar-Incisor Hypomineralization and Biosilicate",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[9,16],null,[35],{"name":36,"affiliation":37,"role":38},"doutoranda","NÃO FILIADO","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Paulla I Zarpellon Barbosa, Mestre","CONTACT","+5516991040404","paullazarpellon@usp.br",{"name":46,"role":42,"phone":33,"phoneExt":33,"email":47},"Paulla IZ Barbosa, Mestre","paulla.zarp@gamil.com",[49,68],{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Faculdade de Odontologia de Ribeirão Preto FORP USP","Ribeirão Preto","São Paulo","14040-904","Brazil","BR",{"type":57,"coordinates":58},"Point",[59,60],-47.81028,-21.1775,{"lat":60,"lon":59},[63,66],{"name":64,"role":42,"phone":65,"phoneExt":33,"email":44},"Profa Msc Paulla Zarpellon Doutoranda","+5591 9 8491 4574",{"name":67,"role":38,"phone":33,"phoneExt":33,"email":33},"PAULLA IADDIA ZARPELLON BARBOSA IZ doutoranda",{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":33},{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},{"type":38,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Paulla Iaddia Zarpellon Barbosa","PESQUISADOR",[76],{"name":77,"class":78},"Conselho Nacional de Desenvolvimento Científico e Tecnológico","OTHER_GOV","100599142","biosilitace-as-a-desensitizing-agentin-hmi-100599142",false,"NCT07080645","BIOSILITACE AS A DESENSITIZING AGENTIN HMI","Biosilicate as a Desensitizing Agent in Teeth With Molar Incisor Hypomineralization in Children: A Randomized Clinical Trial","BDAHMI","Inclusion Criteria:\n\n* Children of both sexes, aged between 6 and 12 years.\n* 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\u002For 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.\n* Children without systemic and\u002For cognitive impairments.\n\nExclusion Criteria:\n\n* Previous use of desensitizing therapy in the last 6 months;\n* Use of analgesic and anti-inflammatory medications during the previous 3 days;\n* Use of orthodontic appliances;\n* Teeth with extensive restorative procedures, such as stainless steel crowns, which prevent the assessment of painful sensitivity;\n* Teeth with amelogenesis imperfecta or dentinogenesis imperfecta;\n* Children with systemic and\u002For cognitive impairments.","ALL","6 Years","12 Years",{"count":91,"type":92},42,"ESTIMATED","INTERVENTIONAL",[95],"NA","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).",[98,99,100],"Sensitive Dentin","Hypomineralization Molar Incisor","Pain",[102,103,104,105,106,107],"pain","Molar-Incisor Hypomineralization","biosilicate","dentin hypersensitivity","tooth enamel","child","NOT_YET_RECRUITING","2025-07-20",{"date":111,"type":112},"2025-07-23","ACTUAL",{"date":114,"type":92},"2025-07-30",{"date":116,"type":92},"2025-11-15",{"name":5,"class":6},2]