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OpenTrials
Completed

NCT Number: NCT07143370

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

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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Key information

Conditions

Orthodontic Aligner Communicable Diseases Disease Attributes Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Microbial colonization of the tooth surface

    Time frame: 1 week Immediately following aligner wear

    Assessed using a swab to the tooth surface (three times, once for each aligner)

  2. Microbial composition of inner surface biofilm of aligners

    Time frame: 1 week Immediately following aligner wear

    Assessed using a swab of the inside of each aligner (three times, once for each aligner)

Secondary outcomes

  1. Patient perception of clear aligners

    Time frame: Approximately 6 weeks

    Assessed using a 11 question survey (9 questions use a likert like scale of 0(poor)-10(excellent))

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Microbial Colonization in 3D Printed Orthodontic Clear Aligners

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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