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NCT Number: NCT07790315

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

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.

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Key information

Conditions

Malocclusion of Anterior Teeth Malocclusion Class II Malocclusion in Children

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Clear aligner fabricated from PETG thermoplastic material

Primary outcomes

  1. Pain intensity during clear aligner therapy

    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.

    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.

Secondary outcomes

  1. Mucosal ulceration or soft-tissue trauma related to aligner wear

    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.

    Presence or absence of ulceration or trauma from the aligner material, recorded by patient report and/or clinical assessment.

  2. Tooth sensitivity

    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.

    Presence or absence of sensitivity in any specific tooth as reported by the participant.

  3. Tooth mobility

    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.

    Presence or absence of tooth mobility reported or detected during follow-up.

  4. Allergic symptoms or material-related adverse reaction

    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.

    Any symptoms suggestive of allergy or adverse reaction to the aligner material will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

HARIS KHAN, BDS, FCPS

CONTACT

[email protected]

+923336159951

Hani Javed, BDS

CONTACT

[email protected]

03243789646

Sponsors and collaborators

Lead sponsor

CMH Lahore Medical College and Institute of Dentistry

Other

Registry information

Official study title

Patient-Reported Outcomes for Different Orthodontic Thermoplastics for Clear Aligners: A Randomized Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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