Malocclusion Class II, Malocclusion in Children, Malocclusion of Anterior Teeth
Conditions
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.
Detailed description
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.
Interventions
DEVICEDevice / 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.
Sponsors
CMH Lahore Medical College and Institute of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double masking: participant and outcome assessor
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during clear aligner therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Presence or absence of ulceration or trauma from the aligner material, recorded by patient report and/or clinical assessment. |
| 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. | Presence or absence of sensitivity in any specific tooth as reported by the participant. |
| 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. | Presence or absence of tooth mobility reported or detected during follow-up. |
| 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. | Any symptoms suggestive of allergy or adverse reaction to the aligner material will be recorded. |
Countries
Pakistan
Contacts
CONTACTHARIS KHAN, BDS, FCPS
CONTACTHani Javed, BDS
PRINCIPAL_INVESTIGATORHARIS KHAN, BDS,FCPS
CMH Lahore medical college and IOD
Outcome results
None listed