[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bracket-bonding\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bracket-bonding":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100599971","a-split-mouth-clinical-trial-evaluating-the-bond-failure-rate-of-a-new-etch-free-orthodontic-adhesive-100599971",false,"NCT07091422","A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive","Inclusion Criteria:\n\nPatients aged 14 to 35 years\n\nRequiring comprehensive fixed orthodontic treatment with brackets on both arches\n\nGood general health with no contraindications to orthodontic treatment\n\nPresence of at least 10 permanent teeth per arch suitable for bracket bonding\n\nAbility and willingness to comply with study visits and follow-up for at least 12 months\n\nParent\u002Fguardian consent and child assent obtained as appropriate\n\nExclusion Criteria:\n\nPresence of systemic diseases or conditions that affect oral health or healing (e.g., uncontrolled diabetes, immunosuppression)\n\nTeeth with significant enamel defects, restorations, or caries in bonding areas\n\nPatients currently undergoing or who have undergone orthodontic treatment previously\n\nHistory of allergy or sensitivity to dental adhesives or related materials\n\nPatients with poor oral hygiene or active periodontal disease\n\nUse of medications known to affect tooth enamel or oral tissues (e.g., long-term corticosteroids)\n\nInability to attend follow-up visits or anticipated lack of compliance\n\nParticipation in another clinical trial that could interfere with study outcomes",true,"ALL","14 Years","35 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized, split-mouth clinical trial will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and enamel damage. The etch-free adhesive under investigation is designed to simplify the bonding procedure while preserving enamel integrity.\n\nTwenty orthodontic patients starting treatment with braces will participate. For each patient, one side of the mouth (left or right) will be randomly assigned to receive the etch-free adhesive, while the opposite side will receive the conventional adhesive with acid etching. This intra-patient design allows a direct comparison under identical oral conditions.\n\nParticipants will be followed for 12 months. Bracket failures, bonding time, ease of adhesive removal, enamel surface condition after debonding, and the presence of white spot lesions will be recorded. If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for orthodontic patients.",[27,28,29,30],"Bracket Bonding","Orthodontic Treatment","Dental Adhesives\u002FRestorations Performance","White Spot Lesion of Tooth",[32,33,34,35,36,37],"Etch-Free Adhesive","Orthodontic Bonding","Bracket Failure","Split-Mouth Trial","White Spot Lesions","Orthodontics Clinical Trial","RECRUITING","2025-11-05",{"date":41,"type":42},"2025-11-10","ACTUAL",{"date":39,"type":42},{"date":45,"type":21},"2026-12-01",{"name":47,"class":48},"University of Maryland, Baltimore","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":15,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100568775","orthodontic-bracket-bonding-100568775","NCT06685614","Orthodontic Bracket Bonding","Orthodontic Bracket Bonding (OBB)","OBB","Inclusion Criteria:\n\ni. Patients with a fully erupted permanent dentition. ii. Orthodontic treatment plans that do not require extractions (excluding wisdom teeth).\n\niii. Patients who have not previously undergone orthodontic treatment. iv. Complete dentition (excluding wisdom teeth). v. Adult patients aged 20 years or older.\n\nExclusion Criteria:\n\ni. Patients requiring extraction of teeth other than wisdom teeth. ii. Fixed prostheses on teeth other than molars. iii. Significant tooth morphology defects requiring fixed prosthetic restorations.\n\niv. Missing teeth (excluding wisdom teeth). v. Patients with fractured crowns or large restorations on the buccal surfaces of crowns.\n\nvi. Teeth with severe rotation or crowding that may impede direct bonding or tray placement.","20 Years",{"count":60,"type":21},220,[24],"Accurate bracket positioning is crucial for effective fixed orthodontic treatment and a core component of orthodontic specialist training. Clinically, two main bonding techniques exist: direct and indirect. Due to limited high-quality trials, there is no conclusive evidence favoring direct or traditional indirect bonding for accuracy. Advances in digital dentistry have further optimized indirect bonding; 3D software allows orthodontists to position virtual brackets for digital tooth alignment, and CAD\u002FCAM technology enables the production of digitally assisted transfer trays. This project will conduct a prospective randomized controlled trial to compare the effectiveness of different bonding methods including traditional direct bonding, traditional indirect bonding, indirect bonding using 3D-printed transfer tray, and indirect bonding using vacuum-formed transfer tray made with 3D-printed models. Outcomes will include bracket placement accuracy, chairside time, bonding failure rate, treatment adjustments, and cast-radiograph evaluation. Despite current costs of CAD\u002FCAM in orthodontics, this study aims to train orthodontic residents, optimize patient care, and foster collaboration across orthodontic specialists and industry. The alternative hypotheses are: (1) Significant differences exist in bracket positioning accuracy across bonding techniques; (2) Bonding techniques vary significantly in chairside time, bonding failure rates, incidence of bracket repositioning, and additional tooth adjustments.",[27],[65,66,67,68],"computer-aided design and computer-aided manufacturing","orthodontics","bracket bonding","digital dentistry","NOT_YET_RECRUITING","2024-11-11",{"date":72,"type":42},"2024-11-12",{"date":74,"type":21},"2024-11-10",{"date":76,"type":21},"2029-11-09",{"name":78,"class":48},"National Taiwan University Hospital"]