Malocclusion of Anterior TeethNCT07790315
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
A study testing Device / orthodontic clear aligner material in people with Malocclusion of Anterior Teeth and Malocclusion in Children, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion of Anterior Teeth, Malocclusion in Children, Malocclusion Class II
- What is being tested?
- Device / orthodontic clear aligner material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
CMH Lahore Medical college and institue of dentistry
Lahore, Punjab Province, 54000
HARIS KHAN, BDS,FCPS, 03336159951, drhariskhan@gmail.com
Hani Javiad, BDS, 03243789646, hanijavaid@hotmail.com
About this study
Official title: Patient-Reported Outcomes for Different Orthodontic Thermoplastics for Clear Aligners: A Randomized Controlled Clinical Trial
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.
Read the 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.
- Being tested
- Device / orthodontic clear aligner material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device / orthodontic clear aligner materialDevice
Also called Clear aligner fabricated from PETG thermoplastic material
Clear aligners fabricated from polyethylene terephthalate glycol (PETG) thermoplastic material. Aligners will be worn for 10 days before progression to the next aligner.
Device / orthodontic clear aligner materialDevice
Clear aligners fabricated from thermoplastic polyurethane (TPU) material. Aligners will be worn for 10 days before progression to the next aligner.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Device / orthodontic clear aligner material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Presence or absence of ulceration or trauma from the aligner material, recorded by patient report and/or clinical assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start10 Aug 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion of Anterior TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HARIS KHAN, BDS,FCPS, Principal investigator, CMH Lahore medical college and IOD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790315
- Sponsor's protocol ID
- 194/ERC/CMH/LMC
- Other IDs
- 449/L-ORIC/CMH LMC
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes for Different Orthodontic Thermoplastics for Clear Aligners: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07790315
- Acronym / sponsor ID
- 194/ERC/CMH/LMC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm A: PETG clear aligners | Experimental | Device: Device / orthodontic clear aligner materialParticipants 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. |
| Experimental Arm B: TPU clear aligners | Experimental | Device: Device / orthodontic clear aligner materialParticipants 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. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- • Patient aged between 15 and 30 years.
Key exclusion criteria (4 listed)
- • Syndromic patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device / orthodontic clear aligner materialAlso: Clear aligner fabricated from PETG thermoplastic materialClear aligners fabricated from polyethylene terephthalate glycol (PETG) thermoplastic material. Aligners will be worn for 10 days before progression to the next aligner. | Device | Experimental Arm A: PETG clear aligners |
| Device / orthodontic clear aligner materialClear aligners fabricated from thermoplastic polyurethane (TPU) material. Aligners will be worn for 10 days before progression to the next aligner. | Device | Experimental Arm B: TPU clear aligners |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HARIS KHAN, BDS,FCPS principal investigator
CMH Lahore medical college and IOD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device / orthodontic clear aligner material in people with Malocclusion of Anterior Teeth and Malocclusion in Children, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HARIS KHAN, BDS, FCPS (+923336159951, drhariskhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.