[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07215598":3,"trial-entities:NCT07215598":116,"trial-summary:NCT07215598":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":43,"secondary_outcomes":54,"sex":68,"minimum_age":69,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":83,"locations":86,"central_contacts":96,"overall_officials":97,"references":98,"see_also_links":112},"NCT07215598","HP-00115664","Split-Mouth Comparison of Invisalign Attachments","Accuracy of Invisalign Attachments: A Split-Mouth Comparative Study of Optimized and Conventional Designs","ENROLLING_BY_INVITATION","2028-07","2026-01","2026-02-10","2025-11-20","University of Maryland, Baltimore","OTHER",false,"This study evaluates how accurately the attachments used in Invisalign treatment (Align Technology Inc., San Jose, CA, USA) match their planned shapes and sizes in the ClinCheck software (ClinCheck®, Align Technology Inc., San Jose, CA, USA). Attachments are small tooth-colored bumps that help clear aligners grip the teeth and move them effectively.\n\nThe investigators are comparing two types of attachments: optimized and conventional, to determine which is bonded to the tooth more accurately and maintains its shape better over time. Participants beginning Invisalign treatment will have attachments placed as part of their normal care. Digital scans will be taken immediately after placement and during follow-up visits to assess attachment accuracy and wear.\n\nThe goal is to identify which attachment design provides greater precision and durability to improve the predictability and efficiency of Invisalign treatment planning.",null,[19,20,21],"Wear, Restoration","Volume Assessment","Clear Aligner Appliance",[23,24,25,26,27],"volume assessment","invisalign","clear aligner","digital orthodontics","attachment wear","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},30,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","Composite Aligner Attachment","Composite aligner attachments are small, tooth-colored resin bumps bonded to specific teeth during Invisalign treatment to enhance aligner retention and force application. These attachments are digitally planned in ClinCheck software and fabricated using manufacturer-provided templates. In this study, two designs: optimized and conventional, will be compared for their accuracy and durability using 3D digital scans at multiple time points.",[41,42],"Conventional","Optimized",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Attachment Volume Accuracy","Quantitative comparison of planned versus bonded Invisalign attachment volumes measured using 3D (three dimensional) digital scans. Each bonded attachment will be segmented from intraoral STL (Standard Tessellation Language) files and superimposed onto the corresponding planned ClinCheck model. The absolute difference in attachment volume (in mm³) between planned and bonded models will be calculated to assess bonding accuracy for optimized and conventional designs.","1 month",{"measure":49,"description":50,"timeFrame":47},"Attachment Active Surface Area Accuracy","Quantitative difference in attachment active surface area using intraoral 3D scans. STL models obtained at baseline (immediately after bonding) and at 1 month will be superimposed to calculate difference in active surface area (mm²). The mean difference between planned and bonded surface areas will be compared for optimized and conventional attachment designs to evaluate bonding precision.",{"measure":52,"description":53,"timeFrame":47},"Positional Accuracy","Difference between planned and bonded attachment position, measured as centroid displacement (mm) after 3D registration of STL models at baseline and 1 month.",[55,59,62,65],{"measure":56,"description":57,"timeFrame":58},"Volume Reduction Over Time","Quantitative change in attachment volume across follow-up using serial intraoral 3D scans. STL models acquired at baseline (immediately after bonding), 1, 3, and 6 months will be superimposed to calculate absolute loss in attachment volume (mm³) for optimized and conventional designs.","6 months",{"measure":60,"description":61,"timeFrame":58},"Volume Loss (Percentage)","Relative change in attachment volume expressed as a percentage of the baseline volume. STL models from baseline, 1, 3, and 6 months will be analyzed to calculate mean percent reduction (%) in attachment volume for optimized and conventional designs.",{"measure":63,"description":64,"timeFrame":58},"Active Surface Area Change Over Time","Longitudinal change in the active surface area of bonded attachments measured from serial intraoral 3D scans. Segmented STL models at baseline (immediately after bonding), 1, 3, and 6 months will be registered to compute absolute change in active surface area (mm²) for optimized and conventional designs.",{"measure":66,"description":67,"timeFrame":58},"Active Surface Area Change (Percentage)","Relative change in attachment active surface area expressed as a percentage of the baseline value. STL models obtained at baseline and at 1, 3, and 6 months will be analyzed to calculate mean percent reduction (%) in active surface area for optimized and conventional attachments.","ALL","18 Years",{"inclusion":71,"exclusion":76,"raw_text":82},[72,73,74,75],"Adults aged18 years or older.","Patients initiating Invisalign treatment with planned composite attachments.","Ability to provide written informed consent and agree to additional research intra-oral scans.","Good oral hygiene and absence of active periodontal disease at enrollment.",[77,78,79,80,81],"Extensive dental restorations (composites, crowns, veneers) on study teeth that could interfere with attachment bonding.","Enamel defects or severe wear on study tooth surfaces affecting bonding accuracy.","Contraindications to digital intraoral scanning (e.g., severe gag reflex, metallic prostheses preventing accurate imaging).","Severe tooth malposition that would compromise accurate attachment placement.","Poor oral hygiene or active periodontal disease at enrollment and\u002For if the patient develops poor oral hygiene or active periodontal disease during treatment.","Inclusion Criteria:\n\n* Adults aged18 years or older.\n* Patients initiating Invisalign treatment with planned composite attachments.\n* Ability to provide written informed consent and agree to additional research intra-oral scans.\n* Good oral hygiene and absence of active periodontal disease at enrollment.\n\nExclusion Criteria:\n\n* Extensive dental restorations (composites, crowns, veneers) on study teeth that could interfere with attachment bonding.\n* Enamel defects or severe wear on study tooth surfaces affecting bonding accuracy.\n* Contraindications to digital intraoral scanning (e.g., severe gag reflex, metallic prostheses preventing accurate imaging).\n* Severe tooth malposition that would compromise accurate attachment placement.\n* Poor oral hygiene or active periodontal disease at enrollment and\u002For if the patient develops poor oral hygiene or active periodontal disease during treatment.",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"University of Maryland School of Dentistry","Baltimore","Maryland","21201","United States",{"lat":94,"lon":95},39.29038,-76.61219,[],[],[99,103,106,109],{"pmid":100,"type":101,"citation":102},"40778386","BACKGROUND","Muthuswamy Pandian S, Subramanian AK, Vaiid N. Comparison of efficacy and accuracy of tooth movements in optimized and conventional attachments of clear aligners - A systematic review and meta-analysis. J Oral Biol Craniofac Res. 2025 Sep-Oct;15(5):1123-1133. doi: 10.1016\u002Fj.jobcr.2025.07.019. Epub 2025 Jul 29.",{"pmid":104,"type":101,"citation":105},"38369617","Li Q, Yang K. Surface wear of attachments in patients during clear aligner therapy: a prospective clinical study. Prog Orthod. 2024 Feb 19;25(1):7. doi: 10.1186\u002Fs40510-023-00506-y.",{"pmid":107,"type":101,"citation":108},"37314488","Fausto da Veiga Jardim A, Curado de Freitas J, Estrela C. Surface wear and adhesive failure of resin attachments used in clear aligner orthodontic treatment. J Orofac Orthop. 2024 May;85(Suppl 1):52-62. doi: 10.1007\u002Fs00056-023-00471-5. Epub 2023 Jun 14.",{"pmid":110,"type":101,"citation":111},"37895792","Bellocchio AM, Portelli M, Ciraolo L, Ciancio E, Militi A, Peditto M, Barbera S, Nucera R. Evaluation of the Clinical Variables Affecting Attachment Reproduction Accuracy during Clear Aligner Therapy. Materials (Basel). 2023 Oct 23;16(20):6811. doi: 10.3390\u002Fma16206811.",[113],{"label":114,"url":115},"Invisalign Attachments explanation","https:\u002F\u002Fwww.invisalign.com\u002Fresources\u002Fliving-with-invisalign\u002Finvisalign-attachments",{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Malocclusion",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]