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.
• 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.
• 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.
Parallel
Device / orthodontic clear aligner material
DeviceClear 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
DeviceClear aligners fabricated from thermoplastic polyurethane (TPU) material. Aligners will be worn for 10 days before progression to the next aligner.
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.
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/or clinical assessment.
Tooth sensitivity
Presence or absence of sensitivity in any specific tooth as reported by the participant.
Tooth mobility
Presence or absence of tooth mobility reported or detected during follow-up.
Allergic symptoms or material-related adverse reaction
Any symptoms suggestive of allergy or adverse reaction to the aligner material will be recorded.
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