NCT07790315|Recruiting
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · CMH lahore medical college and institute of dentistry
interventional
34
1 country
1
Study Start
August 10, 2026
Actual (reported)Primary Completion
November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2026
Actual (reported)August 10, 2026
Actual (reported)August 27, 2026
Actual (reported)November 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Mucosal ulceration or soft-tissue trauma related to aligner wear
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
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
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
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.
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.
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.
Clear aligners fabricated from polyethylene terephthalate glycol (PETG) thermoplastic material. Aligners will be worn for 10 days before progression to the next aligner.
CMH Lahore Medical college and institue of dentistry
Lahore, Punjab Province, 54000, Pakistan
HARIS KHAN, BDS,FCPS
CMH Lahore medical college and IOD
First Submitted
August 7, 2026
First Posted
August 27, 2026
Study Start
August 10, 2026
Actual (reported)Primary Completion
November 15, 2026
EstimatedClear aligners fabricated from thermoplastic polyurethane (TPU) material. Aligners will be worn for 10 days before progression to the next aligner.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 16, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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