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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: CMH Lahore Medical College and Institute of Dentistry • ClinicalTrials.gov ID: NCT07790315

Registry updated: 2026-09-16
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Description

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.

Interventions

  • Device / orthodontic clear aligner material (Device)
    Clear aligners fabricated from polyethylene terephthalate glycol (PETG) thermoplastic material. Aligners will be worn for 10 days before progression to the next aligner.
  • Device / orthodontic clear aligner material (Device)
    Clear aligners fabricated from thermoplastic polyurethane (TPU) material. Aligners will be worn for 10 days before progression to the next aligner.

Eligibility criteria

Inclusion Criteria: * • Patient aged between 15 and 30 years. * Permanent dentition, with all permanent teeth from first molar to first molar present. * Mild to moderate crowding less than 8 mm. * Non-extraction orthodontic treatment plan. * Ability and willingness to wear aligners for the required time. * Willingness to attend regular visits during orthodontic treatment. Exclusion Criteria: * • Syndromic patients. * Known allergy to thermoplastic materials. * Patients with systemic diseases that may affect orthodontic treatment or outcome assessment. * Patients requiring extraction as part of orthodontic treatment.

Conditions

Malocclusion of Anterior Teeth Malocclusion in Children Malocclusion Class II

Locations

  • CMH Lahore Medical college and institue of dentistry — Lahore, Punjab Province, Pakistan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record