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

NCT ID: NCT07143370

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2025-10-17

Brief Summary

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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.

Detailed Description

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Conditions

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Orthodontic Aligner Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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3D printed clear aligner TC-85

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

Group Type EXPERIMENTAL

Thermoformed clear aligner

Intervention Type 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

Intervention Type 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

Intervention Type 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.

3D printed clear aligner TA-28

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

Group Type EXPERIMENTAL

Thermoformed clear aligner

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Thermoformed clear aligner

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

Group Type EXPERIMENTAL

Thermoformed clear aligner

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Thermoformed 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.

Intervention Type DEVICE

3D 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.

Intervention Type DEVICE

3D 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Aron Aliaga del Castillo

Clinical Assistant Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aron Aliaga del Castillo, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00268846

Identifier Type: -

Identifier Source: org_study_id