[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586989":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Giomer based sealant applied on Permanent Molars Affected by MIH","EXPERIMENTAL","* Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).\n* Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel An adequate amount of primer will be dispensed on the enamel surface of the pit and fissure using a brush then will be left undisturbed for 5sec. Gentle air blow for 3 sec and then dryness with stronger stream of air until a thin and uniform bonding layer is obtained.\n* The giomer sealant (BeautiSealant, Shofu, Kyoto, Japan) will be applied into the occlusal fissures applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the fl",[13],"Procedure: Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH",{"label":15,"type":16,"description":17,"interventionNames":18},"Resin based sealant applied on permanent molars affected by MIH","ACTIVE_COMPARATOR","* Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).\n* Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel\n* The resin sealant will be applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow into the pit and fissures. Photo - curing for the sealant will be done for 20 seconds using LED light curing unit. The tip of the light will be held as close as possible to the sealant, without actually touching the sealant.",[19],"Procedure: Resin based sealant applied on Permanent Molars Affected by MIH",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH","* Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).\n* Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel An adequate amount of primer will be dispensed on the enamel surface of the pit and fissure using a brush then will be left undisturbed for 5sec. Gentle air blow for 3 sec and then dryness with stronger stream of air until a thin and uniform bonding layer is obtained.\n* The giomer sealant (BeautiSealant, Shofu, Kyoto, Japan) will be applied into the occlusal fissures applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Resin based sealant applied on Permanent Molars Affected by MIH","Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow).\n\n* Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel\n* The resin sealant (UltraSeal XT™ hydro™) will be applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow into the pit and fissures. Photo - curing for the sealant will be done for 20 seconds using LED light curing unit. The tip of the light will be held as close as possible to the sealant, without actually touching the sealant.\n\nthe surfaces will be checked with an explorer to ensure that no voids were present.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Nayera Mohammed Ali Ali, BDS","CONTACT","00201112666703","naira.ali@dentistry.cu.edu.eg",[38],{"facility":5,"status":26,"city":39,"state":26,"zip":26,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Cairo","Egypt","EG",{"type":43,"coordinates":44},"Point",[45,46],31.24967,30.06263,{"lat":46,"lon":45},[49],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":50},"naira.ali@dentistry.cu.edu.egC",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nayera Mohammed","Principal Investigator","100586989","clinical-performance-of-giomer-preceded-by-etching-versus-resin-based-sealants-applied-on-permanent-molars-affected-by-molar-incisor-hypo-mineralization-100586989",false,"NCT06922552","Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization","Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Healthy children aged 6-14 years who are diagnosed with mild (MIH) according to European Academy of Pediatric Dentistry (EAPD) criteria which includes demarcated enamel opacities (white, creamy, or yellow to brownish), that may induce sensitivity to external stimuli without enamel breakdown.\n\n  * Cooperative children.\n  * Presenting at least one first permanent molar (FPMs) that were fully erupted and indicated for non-invasive fissure sealant.\n  * Medically fit Children (ASA I).\n\nExclusion Criteria:\n\n* Children have hypomineralized (FPMs) with post-eruptive breakdown, cavitated and non-cavitated carious lesions, restorations, or fixed orthodontic appliances.\n* Enamel defects due to a condition other than (MIH).\n* Parents are not willing to join.\n* Molars that cannot be isolated using rubber dam.\n* Uncooperative children.\n* Medically unfit children (other than ASA I).","ALL","6 Years","14 Years",{"count":66,"type":67},56,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of the study is to evaluate the clinical performance of giomer sealant preceded by etching versus resin-based sealants applied on first permanent molars affected by molar incisor hypomineralization (MIH)\n\nThe main question it aims to answer is :\n\nWill the use of Giomer (Beautisealant, Shofu, Kyoto, Japan) Preceded by Etching result in similar clinical performance as Resin-Based Sealants(UltraSeal XT™ Plus™ by Ultradent) Applied on Permanent Molars Affected by Molar-Incisor Hypomineralization?",[73],"Molar Incisor Hypomineralization",[75,76,77,78,79],"MIH","Giomer based sealants","Molar Incisor hypomineralization","Sealants","Rein based sealants","NOT_YET_RECRUITING","2025-04-11",{"date":83,"type":84},"2025-04-16","ACTUAL",{"date":86,"type":67},"2025-06",{"date":88,"type":67},"2026-06",{"name":5,"class":6},1]