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This study is being done to compare conventional clear aligners with 3D printed clear aligners to assess if there is any significant difference between the microbial colonization of these appliances. The 3D printed aligner material and conventional aligner materials are being used for investigational purposes and have been approved for their use in fabricating clear aligners for orthodontic tooth movement, but not for the purposes of our study, which is for the fabrication of clear passive aligners to assess microbial colonization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed clear aligner TC-85 | Experimental | Results compiled for this aligner from all orders of aligner assignments. |
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| 3D printed clear aligner TA-28 | Experimental | Results compiled for this aligner from all orders of aligner assignments. |
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| Thermoformed clear aligner | Experimental | Results compiled for this aligner from all orders of aligner assignments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermoformed clear aligner | Device | All participants will receive a thermoformed aligner fabricated from polyethylene terephthalate glycol (PETG) material. This aligner is made from using an intraoral scan to print a 3D model of their maxillary dentition, that is then used for the thermoforming process. This aligner will be worn 20-22 hrs/day for 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial colonization of the tooth surface | Assessed using a swab to the tooth surface (three times, once for each aligner) | 1 week Immediately following aligner wear |
| Microbial composition of inner surface biofilm of aligners | Assessed using a swab of the inside of each aligner (three times, once for each aligner) | 1 week Immediately following aligner wear |
| Measure | Description | Time Frame |
|---|---|---|
| Patient perception of clear aligners | Assessed using a 11 question survey (9 questions use a likert like scale of 0(poor)-10(excellent)) | Approximately 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aron Aliaga del Castillo, DDS, MS, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3D printed clear aligner TC-85 | Device | All participants will receive a 3D printed aligner fabricated from TC-85 resin. This aligner will be made using an Stereolithography (STL) file from their intraoral scan to design the clear aligner and then will be fabricated using the SprintRay Pro 95 S printer. This aligner will be worn 20-22 hrs/day for 1 week. |
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| 3D printed clear aligner TA-28 | Device | All participants will receive a 3D printed aligner fabricated from TA-28 resin. This aligner will be made using an STL file from their intraoral scan to design the clear aligner and then will be fabricated using the SprintRay Pro 95 S printer. This aligner will be worn 20-22 hrs/day for 1 week. |
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