[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"orthodontic-appliances-fixed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:orthodontic-appliances-fixed":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100611777","effect-of-mi-paste-plus-on-streptococcus-mutans-and-white-spot-lesions-in-fixed-orthodontics-100611777",false,"NCT07244991","Effect of MI Paste Plus™ on Streptococcus Mutans and White Spot Lesions in Fixed Orthodontics","Effect of MI Paste Plus™ on Streptococcus Mutans Counts and White Spot Lesions in Patients With Fixed Orthodontic Appliances: A Triple-Blind Clinical Trial","MIPASTEORTHO","Inclusion Criteria:\n\n* Age between 5 and 45 years.\n* Indication for fixed orthodontic treatment, either with fixed auxiliary appliances (including orthopedic devices) or brackets with or without auxiliary components.\n* General good health with no systemic diseases affecting oral health.\n\nExclusion Criteria:\n\n* Advanced white-spot lesions with untreated dentin involvement.\n* Presence of active untreated dental caries at baseline.\n* Antibiotic therapy within the previous two months.\n* Previous diagnosis of molar-incisor hypomineralization (MIH).\n* History of immunosuppression.\n* Iron-deficiency anemia or other clinically relevant hematological disorders.\n* Parafunctional habits such as lip sucking or finger sucking.\n* Use of any type of dental prosthesis.\n* Smoking or tobacco use.\n* Documented allergy to nickel.\n* Requirement for orthodontic treatment using removable appliances or clear aligners.",true,"ALL","5 Years","45 Years",{"count":22,"type":23},200,"ESTIMATED","INTERVENTIONAL",[26],"NA","Background This study is part of a doctoral research project at Universidad Cardenal Herrera CEU (Spain), directed by Prof. Santiago Arias de Luxán and conducted by doctoral candidate Shirli Kelmendi within the PhD program in Translational Medicine.\n\nFixed orthodontic appliances complicate oral hygiene by creating retention areas that favor bacterial colonization and alter microbial balance. These conditions increase plaque accumulation and Streptococcus mutans (S. mutans) proliferation in saliva and plaque. The frequent low-pH environment favors aciduric bacteria such as S. mutans and lactobacilli, promoting enamel demineralization and formation of white spot lesions (WSLs) or cavitations. WSLs appear as opaque white areas due to subsurface mineral loss, mainly in the gingival third of the crown. They may develop as early as one month after bracket placement, while in patients without appliances, progression occurs after at least six months. Increased S. mutans levels have been reported as early as six weeks after treatment start. Risk factors include poor brushing, lack of floss or rinse use, time since last cleaning, and presence of caries or lesions.\n\nIntervention MI Paste Plus (GC, Japan) is a remineralizing cream with 0.20% sodium fluoride (900 ppm) and 10% CPP-ACP (RECALDENT™), providing calcium and phosphate stabilized by casein phosphopeptides. It has antibacterial and remineralizing effects, suitable during or after orthodontic treatment to prevent or reduce WSLs.\n\nObjective To evaluate whether MI Paste Plus during fixed orthodontic treatment reduces S. mutans counts in saliva and\u002For WSL incidence.\n\nStudy Design A prospective, triple-blind, randomized clinical trial, approved by the Ethics Committee of the Ministry of Health of Albania and the Ethics Committee for Human Research of Universidad Cardenal Herrera CEU, Spain.\n\nThe study will include 200 patients (100 per group) from two orthodontic clinics in Tirana, Albania. Participants will be stratified by age, risk level, and appliance type, then randomized by third parties.\n\nOutcome Measures Primary variables: S. mutans counts in saliva and number of WSLs after 3 months.\n\nStandardized saliva collection, culturing, and bacterial quantification ensure consistency. Clinical assessments will be performed at 1 and 3 months using QRay Cam Pro (Inspektor Systems, Netherlands) for quantitative fluorescence and ICDAS for visual inspection.\n\nData will be analyzed using SPSS\u002FR Commander software.",[29,30,31,32],"Dental Caries","Streptococcus Mutans","Tooth Demineralization","Orthodontic Appliances, Fixed",[34,35,36,37,38,39,40,41,42,43],"MI Paste Plus","Remineralization","Streptococcus mutans","White Spot Lesions","Fixed Orthodontic Appliances","Quantitative Light-Induced Fluorescence","Randomized Controlled Trial","Triple-Blind Study","Albania","CEU Cardenal Herrera University","RECRUITING","2026-03-24",{"date":47,"type":48},"2026-03-27","ACTUAL",{"date":50,"type":48},"2026-01-04",{"date":52,"type":23},"2027-11",{"name":54,"class":55},"Cardenal Herrera University","OTHER",2]