An interventional study of Device / orthodontic clear aligner material and Device / orthodontic clear aligner material in Malocclusion of Anterior Teeth, Malocclusion in Children and Malocclusion Class II, sponsored by CMH Lahore Medical College and Institute of Dentistry. Recruiting at 1 site in Pakistan. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by CMH Lahore Medical College and Institute of Dentistry · Not applicable, Interventional, and Treatment
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.
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.
Eligible 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.
After 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.
The 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.
Patient-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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 34 is close to the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →CMH Lahore Medical College and Institute of Dentistry is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Patient aged between 15 and 30 years.
Exclusion Criteria:
Syndromic patients.
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.
Device: Device / orthodontic clear aligner material
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.
Device: Device / 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.
Also known as: Clear aligner fabricated from PETG thermoplastic material
Clear 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.
Time frame: 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.
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.
Time frame: 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.
Tooth sensitivity
Presence or absence of sensitivity in any specific tooth as reported by the participant.
Time frame: 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.
Tooth mobility
Presence or absence of tooth mobility reported or detected during follow-up.
Time frame: 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.
Allergic symptoms or material-related adverse reaction
Any symptoms suggestive of allergy or adverse reaction to the aligner material will be recorded.
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 3 months is below that.
Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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CMH Lahore Medical College and Institute of Dentistry