[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611777":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":80,"collaborators":83,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":25,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Cardenal Herrera University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: MI Paste Plus","EXPERIMENTAL","Participants assigned to the experimental group will apply MI Paste Plus (GC Corporation, Japan) once daily at night after toothbrushing for three months. The product contains casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 0.20% sodium fluoride (≈900 ppm F-). Application is performed using a clean finger or applicator, avoiding eating, drinking, or rinsing for at least 30 minutes afterward. The goal is to evaluate the preventive effect of MI Paste Plus on Streptococcus mutans levels and enamel white-spot lesions during fixed orthodontic treatment.",[13],"Other: MI Paste Plus (CPP-ACP with Sodium Fluoride)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator: Bioadhesive Gel without Active Ingredients","PLACEBO_COMPARATOR","Participants in the control group will use an identical-appearing bioadhesive oral gel without active ingredients, applied once daily at night after toothbrushing for three months. The gel has the same texture, color, and packaging as MI Paste Plus and serves as the placebo control. Application instructions are identical to those of the experimental group.",[19],"Other: Bioadhesive Oral Gel (Placebo)",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"MI Paste Plus (CPP-ACP with Sodium Fluoride)","Participants in the experimental arm will apply MI Paste Plus once daily at night after toothbrushing for three months. MI Paste Plus is a water-based topical dental cream containing 10% casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 0.20% sodium fluoride (900 ppm F-). The product is applied using a clean finger or applicator and left undisturbed for at least 30 minutes. The intervention aims to reduce Streptococcus mutans counts and prevent enamel demineralization (white-spot lesions) during fixed orthodontic treatment.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Bioadhesive Oral Gel (Placebo)","Bioadhesive oral gel without active ingredients, identical in appearance to MI Paste Plus, applied once daily for three months under the same conditions to maintain blinding.",[15],[31],{"name":32,"affiliation":33,"role":34},"Santiago Arias de Luxán, DMD, PhD","Universidad CEU Cardenal Herrera - Facultad de Ciencias de la Salud","PRINCIPAL_INVESTIGATOR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+34 961 369 000","64358","santiago.arias@uchceu.es",{"name":42,"role":37,"phone":43,"phoneExt":25,"email":44},"Shirli Kelmendi, DMD","+355697721263","shirli.kelmendi@alumnos.uchceu.es",[46,67],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Beaty Dent","RECRUITING","Tirana","Albania","1001","AL",{"type":54,"coordinates":55},"Point",[56,57],19.81866,41.32744,{"lat":57,"lon":56},[60,61,65],{"name":42,"role":37,"phone":43,"phoneExt":25,"email":44},{"name":62,"role":37,"phone":63,"phoneExt":25,"email":64},"Manola Kelmendi, DMD, PhD","+355692271747","manolakelmendi@yahoo.com",{"name":42,"role":66,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":68,"status":69,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Happy Dent","NOT_YET_RECRUITING",{"type":54,"coordinates":71},[56,57],{"lat":57,"lon":56},[74,78,79],{"name":75,"role":37,"phone":76,"phoneExt":25,"email":77},"Enida Petro, DMD, PhD","+355682661316","enipetro@gmail.com",{"name":62,"role":37,"phone":63,"phoneExt":25,"email":64},{"name":42,"role":66,"phone":25,"phoneExt":25,"email":25},{"type":34,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Santiago Arias de Luxán","Professor of Orthodontics",[84,85],{"name":47,"class":6},{"name":86,"class":87},"Institute of Public Health, Albania","OTHER_GOV","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":101,"type":102},200,"ESTIMATED","INTERVENTIONAL",[105],"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.",[108,109,110,111],"Dental Caries","Streptococcus Mutans","Tooth Demineralization","Orthodontic Appliances, Fixed",[113,114,115,116,117,118,119,120,50,121],"MI Paste Plus","Remineralization","Streptococcus mutans","White Spot Lesions","Fixed Orthodontic Appliances","Quantitative Light-Induced Fluorescence","Randomized Controlled Trial","Triple-Blind Study","CEU Cardenal Herrera University","2026-03-24",{"date":124,"type":125},"2026-03-27","ACTUAL",{"date":127,"type":125},"2026-01-04",{"date":129,"type":102},"2027-11",{"name":5,"class":6},2]