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Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Interventions: Device / orthodontic clear aligner material (Device), Device / orthodontic clear aligner material (Device) to Device / orthodontic clear aligner material (Device), Device / orthodontic clear aligner material (Device)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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/wear, T2 at day 1, T3 at day 3, and T4 at day 7.
Trial Details
NCT Number NCT07790315
Lead Sponsor CMH Lahore Medical College and Institute of Dentistry
Conditions
(from sponsor)		 Malocclusion of Anterior Teeth, Malocclusion in Children, Malocclusion Class II
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov