Malocclusion
Conditions
Brief 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. In addition, the study will investigate and compare three different trimline designs: Scalloped, Straight, and Straight Extended.
Interventions
DEVICESureSmile® Clear Aligners
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.
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tooth movement accuracy at subject level across different movement types | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived comfort/pain | 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. | Perceived comfort/pain experienced by subjects will be assessed using a Visual Analogue Scale (VAS) with a Wong Baker face. |
| SureSmile Clear Aligner Refinement rates. | At end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start). | SureSmile Clear Aligner Refinement rates aim to measure the number of refinements required among three different trimline groups. |
| Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation. | From Day 0 up to Retainer Delivery Visit, on average 18 months post Day 0. | Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit. |
Countries
Spain, United Kingdom, United States
Contacts
CONTACTFreja Freedman
CONTACTUlrika Bonander
Outcome results
None listed