NCT07143370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

August 7, 2025

Last Update Submit

November 4, 2025

Conditions

Orthodontic AlignerMicrobial Colonization

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Patient perception of clear aligners

    Approximately 6 weeks

Study Arms (3)

3D printed clear aligner TC-85

EXPERIMENTAL

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

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

3D printed clear aligner TA-28

EXPERIMENTAL

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

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

Thermoformed clear aligner

EXPERIMENTAL

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

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

Interventions

Thermoformed clear alignerDEVICE

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 TA-283D printed clear aligner TC-85Thermoformed clear aligner
3D printed clear aligner TC-85DEVICE

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-283D printed clear aligner TC-85Thermoformed clear aligner
3D printed clear aligner TA-28DEVICE

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-283D printed clear aligner TC-85Thermoformed clear aligner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Periodontal disease/gingivitis or craniofacial anomalies.
  • Severe tooth crowding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aron Aliaga del Castillo, DDS, MS, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Dentistry

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 27, 2025

Study Start

September 2, 2025

Primary Completion

October 17, 2025

Study Completion

October 17, 2025

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)