MalocclusionNCT07290790
A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.
A study testing SureSmile® Clear Aligners in people with Malocclusion, run by Dentsply Sirona Implants and Consumables at 6 sites in 3 countries.
Trial summary
This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion
- What is being tested?
- SureSmile® Clear Aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 29 Jan 2026to 1 Feb 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well as associated time commitment and follow-ups visits.
- Subject has signed and dated the informed consent form (ICF) .
- Subject aged 18 years or above at time of informed consent.
- Subject has permanent dentition (i.e., all 2nd molars).
- Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile Case Selection Guide.
- Crowding or spacing must be ≤6mm present in one or both arches consistent with level 1 and 2 of case complexity.
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- Midline deviation must be ≤3 mm consistent with level 1 and 2 of case complexity.
- Overjet must be ≤4 mm consistent with level 1 and 2 case complexity.
- Overbite must be ≤3 mm consistent with level 1 and 2 case complexity.
- Anterior open bite must be ≤1 mm, consistent with level 1 and 2 case complexity.
- Intermaxillary elastics may be included within the treatment plan to support sagittal, vertical, or transverse correction within the limits defined under exclusion criteria.
Who cannot join
- Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
- Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide.
- Subjects who have completed aligner therapy within the last 12 months or who are in active orthodontic treatment.
- Subjects with active periodontal disease or other unresolved dental conditions such as active cavities, active periodontal disease.
- Subjects with treatment plans requiring transverse correction requiring expansion greater than 4 mm per arch or 2 mm per quadrant, or any skeletal transverse correction.
- Treatment plans requiring sagittal correction exceeding a half-cusp discrepancy (i.e., >½ unit) in molar or canine relationships.
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- Subjects with treatment plans require vertical correction beyond Level 1 and 2 thresholds (i.e., overbite >3 mm or anterior/posterior open bite >1 mm), or vertical elastics exceeding 3 mm.
- TMJ (Temporo-Mandibular Join) disorders or history of headaches or migraines.
- Participants with known history of plastic allergies.
- Subjects with presence of skeletal discrepancies necessitating orthognathic surgery, rapid palatal expansion, other orthopedic intervention, unilateral or bilateral cross-bites, mandibular deviations in association with the diagnosed malocclusion
- The use of TADs (Temporary Anchor Devices), plates, other fixed anchorage ancillaries or the use of functional appliances (distalizers, growth modification devices), any approach involving orthopedic or skeletal sagittal correction or the use of hybrid fixed appliances are not considered part of the scope of this clinical investigation and these subjects are not eligible.
- Uncontrolled para-functional habits, e.g., bruxism.
- Any other condition that would make the subject unsuitable for participation, including but not limited to:
- Unstable psychiatric illness.
- Recent myocardial infarction (< 3 months*).
- Recent cerebrovascular accident (< 3 months*).
- Recent cardiac-valvular prosthesis placement (< 3 months*).
- Hemorrhagic diathesis.
- Severe liver dysfunction.
- Known or suspected current malignancy.
- Known pregnancy at the time of enrolment.
- Previous enrolment in the present clinical investigation.
- Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
- Participation in another clinical investigation that may interfere with the present clinical investigation.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Costanzo Orthodontics
Fresno, California, 93720
Chichetti, +1 3369701350, drc@cpdentalwellness.com
- Recruiting
Brush 365 Dental
Frisco, Texas, 75035
Mahmood, +1 2145341915, drmahmood@brush365dental.com
- Recruiting
J Chichetti PLLC 2
Huntersville, North Carolina, 28078
Chichetti, +1 3369701350, drc@cpdentalwellness.com
- Not yet recruiting
Center for Orthodontic Excellence
Princeton Junction, New Jersey, 08550
Shah, +1 6097994628, Drshah@coesmiles.com
Spain1 site, 1 recruiting
- Not yet recruiting
Clinica Dental Ortiz Puigpelat
Barcelona, 08028
Salman, +34 (0)20 8303 7051, ortho.admin@thesandford.com
United Kingdom1 site, 1 recruiting
- Not yet recruiting
The Sanford
Bexleyheath, DA6 8AA
Shaffie, +44 7702088334, ortho.admin@thesandford.com
About this study
Official title: A Prospective, Multicenter, Randomized, Post-market Clinical Investigation to Assess the Accuracy of Different Tooth Movements for Patients Undergoing Clear Aligner Therapy (CAT) With SureSmile® Clear Aligners With Three Different Trimlines.
This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements. In addition, the study will investigate and compare three different trimline designs: Scalloped, Straight, and Straight Extended.
- Conditions
- Malocclusion
- Being tested
- SureSmile® Clear Aligners
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureSmile® Clear AlignersDevice
SureSmile® Clear Aligners are Custom-made (EU)/patient matched (US) medical devices made to fit appliance with different diameters and lengths to accommodate subjects with different mouth shapes and sizes.
This clinical investigation consists of three different trimline designs groups:
- SureSmile aligner Scallop trimline design
- SureSmile aligner Straight trimline design
- SureSmile aligner Straight extended trimline design
All pre-treatment, treatment, and post-treatment protocols and materials used in all groups are identical, except for the type of trimline design.
| Study group | Role | What they receive |
|---|---|---|
| Scalloped trimline design | Experimental | SureSmile® Clear Aligner (Group 1) with scalloped trimline design Receives: Device: SureSmile® Clear Aligners |
| Straight trimline design | Experimental | SureSmile® Clear Aligner (Group 2) with straight trimline design Receives: Device: SureSmile® Clear Aligners |
| Extended trimline design | Experimental | SureSmile® Clear Aligner (Group 3) with extended trimline design (2 mm) Receives: Device: SureSmile® Clear Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth movement accuracy at subject level across different movement types
The primary objective of this clinical investigation is to provide a detailed assessment of tooth movement accuracy at subject level across different movement types. For each patient, all teeth will be evaluated in five dimensions of movement:
- Mesiodistal translation [mm]
- Buccolingual translation [mm]
- Intrusive/extrusive movement [mm]
- Mesiodistal angulation [degrees]
- Buccolingual torque [degrees]
Accuracy will be determined by comparing the predicted versus achieved tooth positions for 16 teeth in each subject using the formula:
"Percentage of accuracy" =100 - [(|predicted-achieved| / |predicted|) *100]" Subject effectiveness is the overall mean of all the collected "Percentage of accuracy" values.
Measured: At start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).
Secondary outcomes (3)
Perceived comfort/pain
Perceived comfort/pain experienced by subjects will be assessed using a Visual Analogue Scale (VAS) with a Wong Baker face.
Measured: Every 8 weeks from start of aligner treatment up to to end of aligner treatment according to predetermined treatment plan (on average 6-18 months). Plus every 8 weeks during refinement period, on average 8-12 weeks.
SureSmile Clear Aligner Refinement rates.
SureSmile Clear Aligner Refinement rates aim to measure the number of refinements required among three different trimline groups.
Measured: At end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
Measured: From Day 0 up to Retainer Delivery Visit, on average 18 months post Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start29 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290790
- Sponsor's protocol ID
- C-OR-25-002
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Post-market Clinical Investigation to Assess the Accuracy of Different Tooth Movements for Patients Undergoing Clear Aligner Therapy (CAT) With SureSmile® Clear Aligners With Three Different Trimlines.
- ClinicalTrials.gov ID
- NCT07290790
- Acronym / sponsor ID
- C-OR-25-002
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 18 Dec 2025 (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.
This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements. In addition, the study will investigate and compare three different trimline designs: Scalloped, Straight, and Straight Extended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scalloped trimline design | Experimental | Device: SureSmile® Clear AlignersSureSmile® Clear Aligner (Group 1) with scalloped trimline design |
| Straight trimline design | Experimental | Device: SureSmile® Clear AlignersSureSmile® Clear Aligner (Group 2) with straight trimline design |
| Extended trimline design | Experimental | Device: SureSmile® Clear AlignersSureSmile® Clear Aligner (Group 3) with extended trimline design (2 mm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well as associated time commitment and follow-ups visits.
- Subject has signed and dated the informed consent form (ICF) .
- Subject aged 18 years or above at time of informed consent.
- Subject has permanent dentition (i.e., all 2nd molars).
- Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile Case Selection Guide.
Key exclusion criteria (24 listed)
- Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
- Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide.
- Subjects who have completed aligner therapy within the last 12 months or who are in active orthodontic treatment.
- Subjects with active periodontal disease or other unresolved dental conditions such as active cavities, active periodontal disease.
- Subjects with treatment plans requiring transverse correction requiring expansion greater than 4 mm per arch or 2 mm per quadrant, or any skeletal transverse correction.
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 |
|---|---|---|
| SureSmile® Clear AlignersSureSmile® Clear Aligners are Custom-made (EU)/patient matched (US) medical devices made to fit appliance with different diameters and lengths to accommodate subjects with different mouth shapes and sizes. This clinical investigation consists of three different trimline designs groups: * SureSmile aligner Scallop trimline design * SureSmile aligner Straight trimline design * SureSmile aligner Straight extended trimline design All pre-treatment, treatment, and post-treatment protocols and materials used in all groups are identical, except for the type of trimline design. | Device | Extended trimline design, Scalloped trimline design, Straight trimline design |
Primary outcome
Tooth movement accuracy at subject level across different movement types
Time frame: At start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).
The primary objective of this clinical investigation is to provide a detailed assessment of tooth movement accuracy at subject level across different movement types. For each patient, all teeth will be evaluated in five dimensions of movement: 1. Mesiodistal translation [mm] 2. Buccolingual translation [mm] 3. Intrusive/extrusive movement [mm] 4. Mesiodistal angulation [degrees] 5. Buccolingual torque [degrees] Accuracy will be determined by comparing the predicted versus achieved tooth positions for 16 teeth in each subject using the formula: "Percentage of accuracy" =100 - [(|predicted-achieved| / |predicted|) *100]" Subject effectiveness is the overall mean of all the collected "Percentage of accuracy" values.
3 secondary outcomes
Perceived comfort/pain
Time frame: Every 8 weeks from start of aligner treatment up to to end of aligner treatment according to predetermined treatment plan (on average 6-18 months). Plus every 8 weeks during refinement period, on average 8-12 weeks.
SureSmile Clear Aligner Refinement rates.
Time frame: At end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Time frame: From Day 0 up to Retainer Delivery Visit, on average 18 months post Day 0.
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 11 Aug 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.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SureSmile® Clear Aligners in people with Malocclusion, run by Dentsply Sirona Implants and Consumables at 6 sites in 3 countries.
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 11 inclusion and 24 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain, United Kingdom. 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 Freja Freedman (+46 702107415, freja.freedman@dentsplysirona.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth movement accuracy at subject level across different movement types (time frame: At start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).). 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 11 Aug 2026.