Microbial Colonization in Three Dimensional (3D) Printed Orthodontic Clear Aligners

University of Michigan

Status: Completed

Conditions: Orthodontic Aligner; Microbial Colonization

Treatments: Device: Thermoformed clear aligner; Device: 3D printed clear aligner TC-85; Device: 3D printed clear aligner TA-28

Study type: Interventional

Funder types: Other

Identifiers

NCT07143370

HUM00268846

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

3D printed clear aligner TC-85

Experimental group

Description:

Results compiled for this aligner from all orders of aligner assignments.

Treatment:

Device: 3D printed clear aligner TA-28

Device: 3D printed clear aligner TC-85

Device: Thermoformed clear aligner

3D printed clear aligner TA-28

Experimental group

Description:

Results compiled for this aligner from all orders of aligner assignments.

Treatment:

Device: 3D printed clear aligner TA-28

Device: 3D printed clear aligner TC-85

Device: Thermoformed clear aligner

Thermoformed clear aligner

Experimental group

Description:

Results compiled for this aligner from all orders of aligner assignments.

Treatment:

Device: 3D printed clear aligner TA-28

Device: 3D printed clear aligner TC-85

Device: Thermoformed clear aligner