[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615378":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":28,"studyPopulation":17,"armGroups":29,"interventions":41,"overallOfficials":17,"centralContacts":51,"locations":59,"responsibleParty":78,"collaborators":17,"id":82,"slug":17,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":17,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":17,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":105,"whyStopped":17,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Baghdad","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Bracket Bond Failure Rate","Documented as a percentage of brackets debonded during the 6-month observation period, categorized by location (incisor, canine, premolar) and cause (adhesive failure, cohesive failure, bracket fracture .","6 MONTH",[14],{"measure":15,"description":16,"timeFrame":12},"Adhesive Remnant Index","Adhesive Remnant Index (ARI) scores will be assessed to determine failure mode",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Evaluating the clinical effectiveness of enamel etching\u002Fpriming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"SINGLE","multi-center, parallel-group, single-blinded randomized clinical trial conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines for orthodontic research.",[27],"PARTICIPANT","To evaluate the clinical performance of a newly developed self-etch primer (M-SEP) versus P-SEP in bonding metallic orthodontic brackets to different teeth, verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.\n\nObjectives:\n\nPrimary; Evaluating the clinical effectiveness of enamel etching\u002Fpriming with M-SEP versus P-SEP in achieving clinically adequate bond strengths throughout the assessment of bracket failure rate over a period of 6 months.\n\nSecondary;\n\n1. Examining the potential enamel remineralization effect of both systems via the use of Fe-SEM and Raman spectroscopy.\n2. Assessing the amount of remnant adhesive left post bracket failure (for both systems) via the use of SEM and digital photography.\n3. Measuring the total time required for remnant adhesive removal post bracket failure\u002Fdebonding.\n4. Evaluating patient perception during bracket failure\u002Fdebonding and subsequent adhesive removal procedure.",[30,37],{"label":31,"type":32,"description":33,"interventionNames":34},"Split-mouth bonding: SEP 1 right\u002FLL vs SEP 2 left\u002FLR","EXPERIMENTAL","Patients receive fixed MBT stainless-steel brackets bonded with two self-etch primers in a split-mouth design. Maxillary right and mandibular left incisors, canines, and premolars are etched with SEP 1; maxillary left and mandibular right counterparts are etched with SEP 2. All teeth are polished with fluoride-free pumice, brackets bonded with Transbond XT, and standard NiTi-stainless-steel archwire sequence used in both arches.",[35,36],"Device: Remineralizing self-etch primer (M-SEP, SEP 1)","Device: Standard self-etch primer (P-SEP, SEP 2)",{"label":38,"type":32,"description":39,"interventionNames":40},"Split-mouth bonding: SEP 1 left\u002FLR vs SEP 2 right\u002FLL","Patients receive the same fixed MBT stainless-steel appliance and archwire sequence as Group A. In this arm, maxillary left and mandibular right incisors, canines, and premolars are etched with SEP 1, while maxillary right and mandibular left counterparts are etched with SEP 2. Bonding follows identical polishing, priming, Transbond XT application, and LED light-curing protocol as in Group A.",[35,36],[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":17},"DEVICE","Remineralizing self-etch primer (M-SEP, SEP 1)","Experimental self-etch primer based on Transbond Plus modified with 7% nano-hydroxyapatite. Applied to labial\u002Fbuccal enamel of incisors, canines, and premolars after pumice prophylaxis; air-dried 3 s, brackets bonded with Transbond XT and LED light-cured 10 s mesial and 10 s distal.",[38,31],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":17},"Standard self-etch primer (P-SEP, SEP 2)","Conventional Transbond Plus self-etch primer used according to manufacturer's instructions for enamel conditioning of incisors, canines, and premolars, followed by Transbond XT adhesive and LED light-curing as above.",[38,31],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":17,"email":56},"DIYAR TAHER AGHA, MSc Candidate","CONTACT","009647705880686","aghadiyar@gmail.com",{"name":58,"role":54,"phone":17,"phoneExt":17,"email":17},"Ali I Ibrahim, Professor",[60],{"facility":61,"status":17,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"College of Dentistry, University of Baghdad - Orthodontic Dept\u002FPostgraduate Clinic","Baghdad","Baghdad Governorate","1417","Iraq","IQ",{"type":68,"coordinates":69},"Point",[70,71],44.40088,33.34058,{"lat":71,"lon":70},[74,77],{"name":75,"role":54,"phone":55,"phoneExt":17,"email":76},"Diyar Taher Agha, MSc Candidate","aghadiyar169@gmail.com",{"name":58,"role":54,"phone":17,"phoneExt":17,"email":17},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Ali I Ibrahim","Professor","100615378",false,"NCT07291830","A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding","Clinical Effectiveness of a Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Full permanent dentition including incisors, canines, premolars, and molars (excepting 3rd molars;\n* Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide,\n* No previous orthodontic treatment with fixed appliances.\n\nExclusion Criteria:\n\n* Participants unable to give informed consent,\n* Had craniofacial anomalies,\n* Require orthognathic surgery as part of their treatment,\n* Had congenital enamel defects.",true,"ALL","12 Years","35 Years",{"count":93,"type":94},45,"ESTIMATED","INTERVENTIONAL",[97],"NA","This randomized clinical trial aims to evaluate the clinical effectiveness of a remineralizing self-etch primer used for orthodontic bracket bonding. The study compares bonding performance, enamel surface effects, and clinical outcomes between the experimental primer and the conventional bonding protocol,verify the potential remineralization effect, and examine the amount of adhesive remnants left on enamel over a period of 6 months.",[100,101],"White Spot Lesions","Enamel Demineralization",[103,104],"Orthodontic Bracket Bonding","Self-Etch Primers","NOT_YET_RECRUITING","2026-05-01",{"date":108,"type":109},"2026-05-07","ACTUAL",{"date":111,"type":94},"2026-05-15",{"date":113,"type":94},"2026-12-30",{"name":5,"class":6},1]