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

NCT07790315 | Not Yet Recruiting

• 2 other identifiers: 194/ERC/CMH/LMC449/L-ORIC/CMH LMC
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion of Anterior Teeth; Malocclusion in Children; Malocclusion Class II

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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.

Study Arms (2)

Experimental Arm A: PETG clear aligners

EXPERIMENTAL

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

Experimental Arm B: TPU clear aligners

EXPERIMENTAL

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

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.

Also known as: Clear aligner fabricated from PETG thermoplastic material

Experimental Arm A: PETG clear aligners

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CMH Lahore Medical College and Institute of Dentistry: lead

Study Sites (1)

CMH Lahore Medical college and institue of dentistry

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

• HARIS KHAN, BDS,FCPS

  CMH Lahore medical college and IOD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HARIS KHAN, BDS, FCPS

CONTACT

+923336159951; drhariskhan@gmail.com

Hani Javed, BDS

CONTACT

03243789646; hanijavaid@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double masking: participant and outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 27, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)