Microbial Colonization, Orthodontic Aligner
Conditions
Brief summary
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.
Interventions
DEVICEThermoformed clear aligner
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.
DEVICE3D printed clear aligner TC-85
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.
DEVICE3D printed clear aligner TA-28
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants are in the permanent dentition * Participants can understand written English instructions * Participants have no history of smoking * Participants will not undergo any active orthodontic treatment.
Exclusion criteria
* Periodontal disease/gingivitis or craniofacial anomalies. * Severe tooth crowding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial colonization of the tooth surface | 1 week Immediately following aligner wear | Assessed using a swab to the tooth surface (three times, once for each aligner) |
| Microbial composition of inner surface biofilm of aligners | 1 week Immediately following aligner wear | Assessed using a swab of the inside of each aligner (three times, once for each aligner) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient perception of clear aligners | Approximately 6 weeks | Assessed using a 11 question survey (9 questions use a likert like scale of 0(poor)-10(excellent)) |
Countries
United States
Outcome results
None listed