[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653604":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":38,"studyPopulation":26,"armGroups":39,"interventions":50,"overallOfficials":61,"centralContacts":66,"locations":76,"responsibleParty":96,"collaborators":26,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":26,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":26,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":26,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"CMH Lahore Medical College and Institute of Dentistry","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity during clear aligner therapy","Pain experienced by the participant will be recorded using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.","During each of the first four aligner cycles: before aligner insertion; immediately after aligner insertion; and 1 day, 3 days, and 7 days after aligner insertion.",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Mucosal ulceration or soft-tissue trauma related to aligner wear","Presence or absence of ulceration or trauma from the aligner material, recorded by patient report and\u002For clinical assessment.",{"measure":18,"description":19,"timeFrame":12},"Tooth sensitivity","Presence or absence of sensitivity in any specific tooth as reported by the participant.",{"measure":21,"description":22,"timeFrame":12},"Tooth mobility","Presence or absence of tooth mobility reported or detected during follow-up.",{"measure":24,"description":25,"timeFrame":12},"Allergic symptoms or material-related adverse reaction","Any symptoms suggestive of allergy or adverse reaction to the aligner material will be recorded.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"TRIPLE","Double masking: participant and outcome assessor",[35,36,37],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a randomized, double-blind, parallel-group clinical trial conducted at the Department of Orthodontics, Institute of Dentistry, CMH Lahore Medical College, Lahore, Pakistan.\n\nEligible participants will be patients aged 15 to 30 years seeking orthodontic treatment with clear aligners. Patients must have permanent dentition from first molar to first molar, mild to moderate crowding less than 8 mm, and a non-extraction treatment plan.\n\nAfter baseline assessment, participants will be randomized in a 1:1 ratio to receive clear aligners fabricated from PETG or TPU. Randomization will use a computer-generated sequence prepared by an independent statistician. Allocation concealment will be maintained using sealed envelopes by staff not involved in trial assessment.\n\nThe principal investigator will plan all aligner cases. Linear movements will be limited to 0.25 mm per aligner. Angular movements will be limited to 2 degrees per aligner, except torque, which will be limited to 1 degree per aligner. Each aligner will be worn for 10 days.\n\nPatient-reported outcomes will be collected by an operator blinded to the aligner material. Participants will also be blinded to the aligner material. Outcomes include pain on a visual analog scale, ulceration or soft-tissue trauma, tooth sensitivity, tooth mobility, and symptoms suggestive of material-related allergy.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Experimental Arm A: PETG clear aligners","EXPERIMENTAL","Participants will receive clear aligners fabricated from polyethylene terephthalate glycol (PETG). Aligners will be planned for routine orthodontic alignment, including proclination, expansion, or interdental enamel reduction when clinically indicated. Each aligner will be worn for 10 days.",[45],"Device: Device \u002F orthodontic clear aligner material",{"label":47,"type":42,"description":48,"interventionNames":49},"Experimental Arm B: TPU clear aligners","Participants will receive clear aligners fabricated from thermoplastic polyurethane (TPU). Aligners will be planned for routine orthodontic alignment, including proclination, expansion, or interdental enamel reduction when clinically indicated. Each aligner will be worn for 10 days.",[45],[51,58],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DEVICE","Device \u002F orthodontic clear aligner material","Clear aligners fabricated from polyethylene terephthalate glycol (PETG) thermoplastic material. Aligners will be worn for 10 days before progression to the next aligner.",[41],[57],"Clear aligner fabricated from PETG thermoplastic material",{"type":52,"name":53,"description":59,"armGroupLabels":60,"otherNames":26},"Clear aligners fabricated from thermoplastic polyurethane (TPU) material. Aligners will be worn for 10 days before progression to the next aligner.",[47],[62],{"name":63,"affiliation":64,"role":65},"HARIS KHAN, BDS,FCPS","CMH Lahore medical college and IOD","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":26,"email":71},"HARIS KHAN, BDS, FCPS","CONTACT","+923336159951","drhariskhan@gmail.com",{"name":73,"role":69,"phone":74,"phoneExt":26,"email":75},"Hani Javed, BDS","03243789646","hanijavaid@hotmail.com",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"CMH Lahore Medical college and institue of dentistry","RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":86,"coordinates":87},"Point",[88,89],74.35071,31.558,{"lat":89,"lon":88},[92,94],{"name":63,"role":69,"phone":93,"phoneExt":26,"email":71},"03336159951",{"name":95,"role":69,"phone":74,"phoneExt":26,"email":75},"Hani Javiad, BDS",{"type":97,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100653604","patient-reported-outcomes-for-different-orthodontic-thermoplastics-used-in-clear-aligners-100653604",false,"NCT07790315","Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners","Patient-Reported Outcomes for Different Orthodontic Thermoplastics for Clear Aligners: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* • Patient aged between 15 and 30 years.\n\n  * Permanent dentition, with all permanent teeth from first molar to first molar present.\n  * Mild to moderate crowding less than 8 mm.\n  * Non-extraction orthodontic treatment plan.\n  * Ability and willingness to wear aligners for the required time.\n  * Willingness to attend regular visits during orthodontic treatment.\n\nExclusion Criteria:\n\n* • Syndromic patients.\n\n  * Known allergy to thermoplastic materials.\n  * Patients with systemic diseases that may affect orthodontic treatment or outcome assessment.\n  * Patients requiring extraction as part of orthodontic treatment.",true,"ALL","15 Years","30 Years",{"count":110,"type":111},34,"ESTIMATED","INTERVENTIONAL",[114],"NA","Clear aligner therapy is an esthetic orthodontic treatment modality that uses removable thermoplastic trays to correct dental alignment. Different thermoplastic materials, including thermoplastic polyurethane (TPU) and polyethylene terephthalate glycol (PETG), may differ in flexibility and mechanical behavior. These material differences may influence patient-reported outcomes such as pain, mucosal ulceration, tooth sensitivity, tooth mobility, and material-related allergic symptoms. This randomized, double-blind, parallel-group clinical trial will compare patient-reported outcomes in patients treated with clear aligners fabricated from TPU versus PETG. Participants requiring non-extraction clear aligner therapy for mild to moderate crowding will be randomly allocated in a 1:1 ratio to receive aligners fabricated from either PETG or TPU. Outcomes will be recorded at five predefined time points after aligner assignment and wear: T0 before aligner wear, T1 immediately after aligner insertion\u002Fwear, T2 at day 1, T3 at day 3, and T4 at day 7.",[117,118,119],"Malocclusion of Anterior Teeth","Malocclusion in Children","Malocclusion Class II","2026-09-14",{"date":122,"type":123},"2026-09-16","ACTUAL",{"date":125,"type":123},"2026-08-10",{"date":127,"type":111},"2026-12-01",{"name":5,"class":6},1]