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

Not Applicable

Active, not recruiting

• Conditions: Orthodontic Aligner; Microbial Colonization

• Registration Number: NCT07143370
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-19
• Study First Posted: 2025-08-27
• Status Verified: 2025-09
• Study Start: 2025-09-02
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-18
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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))

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States