[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618024":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":50,"locations":58,"responsibleParty":77,"collaborators":80,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":30,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":30,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":30,"overallStatus":104,"whyStopped":30,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Çanakkale Onsekiz Mart University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (Standard Local Anesthesia)","ACTIVE_COMPARATOR","Standard local anesthesia and operative restorative treatment only (no adjunctive SDF or cryotherapy).",[13],"Other: Standard Local Anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Intraoral Cryotherapy + Standard Local Anesthesia","EXPERIMENTAL","Intraoral cryotherapy applied before anesthesia, followed by standard local anesthesia and operative restorative treatment.",[13,19],"Other: Intraoral Cryotherapy",{"label":21,"type":16,"description":22,"interventionNames":23},"Silver Diamine Fluoride (SDF) + Standard Local Anesthesia","Silver diamine fluoride applied before anesthesia, followed by standard local anesthesia and operative restorative treatment.",[13,24],"Other: Silver Diamine Fluoride (SDF)",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Standard Local Anesthesia","Local anesthesia will be administered using 1.8 mL articaine HCl with 1:100,000 epinephrine (e.g., Ultracain DS) via a standardized block anesthesia technique prior to operative treatment. (Applied in",[9,15,21],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Intraoral Cryotherapy","Cold application to the buccal mucosa adjacent to the treated tooth for 5 minutes before local anesthetic administration.",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Silver Diamine Fluoride (SDF)","SDF will be applied to the target tooth before local anesthetic administration according to standard clinical application procedures.",[21],[40,43,47],{"name":41,"affiliation":5,"role":42},"Burak Çarıkçıoğlu, Associate Professor","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":46},"Seçkin Aksu, Assistant Professor","Mersin University","STUDY_DIRECTOR",{"name":48,"affiliation":5,"role":49},"Hilal Öztürk, Research Assistant","STUDY_CHAIR",[51,55],{"name":41,"role":52,"phone":53,"phoneExt":30,"email":54},"CONTACT","+905054956091","carikcioglub@gmail.com",{"name":48,"role":52,"phone":56,"phoneExt":30,"email":57},"+905312591404","hilalozturk98@gmail.com",[59,69],{"facility":60,"status":30,"city":61,"state":30,"zip":30,"country":62,"countryCode":30,"cosmosGeoPoint":63,"geoPoint":68,"contacts":30},"Çanakkale Onsekiz Mart University, School of Dentistry","Çanakkale","Turkey (Türkiye)",{"type":64,"coordinates":65},"Point",[66,67],26.41271,40.15552,{"lat":67,"lon":66},{"facility":70,"status":30,"city":71,"state":30,"zip":30,"country":62,"countryCode":30,"cosmosGeoPoint":72,"geoPoint":76,"contacts":30},"Mersin University, School of Dentistry","Mersin",{"type":64,"coordinates":73},[74,75],34.63886,36.81196,{"lat":75,"lon":74},{"type":42,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Burak Carıkcıoglu","Associate Professor",[81],{"name":45,"class":6},"100618024","effects-of-silver-diamine-fluoride-and-intraoral-cryotherapy-on-local-anesthesia-in-mih-affected-molars-100618024",false,"NCT07326241","Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia in MIH-Affected Molars","Effects of Silver Diamine Fluoride and Intraoral Cryotherapy on Local Anesthesia Efficacy in Permanent Molars With Molar-Incisor Hypomineralization","Inclusion Criteria:\n\n* Children aged between 6 and 12 years.\n* Systemically healthy children with no medical conditions that could interfere with dental treatment.\n* Presence of at least one permanent first molar affected by molar-incisor hypomineralization (MIH), diagnosed according to the European Academy of Paediatric Dentistry (EAPD) criteria.\n* Teeth with caries lesions classified as ICDAS II codes 2, 3, 4, 5, or 6.\n* Children with an adequate level of cooperation to allow completion of dental treatment under clinical conditions.\n* Children and their parents\u002Flegal guardians who have read, understood, and signed the informed consent form and agreed to participate in the study.\n\nExclusion Criteria:\n\n* Teeth that are not restorable.\n* Children with a known allergy or hypersensitivity to any materials used in the study, including local anesthetics, silver diamine fluoride, or restorative materials.\n* Presence of spontaneous pain, percussion sensitivity, or other signs\u002Fsymptoms of pulpal pathology in the study tooth.\n* Children with systemic diseases or conditions that could affect pain perception, healing, or cooperation during dental treatment.\n* Children who are unable or unwilling to complete the clinical procedure.",true,"ALL","6 Years","12 Years",{"count":94,"type":95},75,"ESTIMATED","INTERVENTIONAL",[98],"NA","Molar-incisor hypomineralization (MIH) is a developmental enamel defect of unclear etiology that affects permanent first molars and often permanent incisors, leading to increased porosity, hypersensitivity, and poor prognosis. The porous structure of MIH-affected enamel facilitates bacterial penetration, which may cause subclinical pulpal inflammation and reduce the effectiveness of local anesthesia during dental procedures. Achieving adequate anesthesia in children with MIH can be challenging, resulting in increased discomfort, anxiety, and behavioral management difficulties.\n\nCryotherapy has been shown to reduce pain by decreasing local inflammation and slowing nerve conduction, while silver diamine fluoride (SDF) has demonstrated efficacy in reducing dentin hypersensitivity through tubule occlusion, antibacterial activity, and remineralization. This study aims to evaluate the effects of intraoral cryotherapy and silver diamine fluoride application on pain perception and the efficacy of local anesthesia during operative dental procedures in MIH-affected permanent first molars.",[101,102,103],"MIH","Molar-Incisor Hypomineralization","Caries Assessment","NOT_YET_RECRUITING","2025-12-24",{"date":107,"type":108},"2026-01-08","ACTUAL",{"date":110,"type":95},"2026-02-01",{"date":112,"type":95},"2026-04-01",{"name":5,"class":6},2]