Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers

Essraa hassan Hussein Mohamed

Status: Not yet enrolling

Conditions: Clear Orthodontic Retainers; Orthodontic Retention Appliance

Treatments: Device: Multi-Layer Thermoformed Retainer; Device: Direct 3D-Printed Retainer; Device: Single-Layer Thermoformed Retainer

Study type: Interventional

Funder types: Other

Identifiers

NCT07053410

Orthodontic retainers

Details and patient eligibility

About

This study aims to compare two types of orthodontic retainers used after active treatment to maintain teeth position. The retainers are fabricated using either direct 3D-printing or thermoforming methods. The study will evaluate which method provides better dimensional accuracy (fit) and color stability over time. Adult patients who have completed their orthodontic treatment will be randomly assigned to one of three groups, each receiving a different type of retainer. The research is conducted at the Faculty of Dental Medicine, Al-Azhar University - Assiut Branch. The goal is to help orthodontists select the most reliable and durable type of retainer for long-term use.

Full description

This randomized clinical and laboratory study investigates the dimensional accuracy and color stability of orthodontic retainers fabricated using two different techniques: direct 3D printing and thermoforming. Patients who have completed active orthodontic treatment will be recruited and assigned to three groups. Group T1 will receive 3D-printed retainers, Group T2 will receive single-layer thermoformed retainers, and Group T3 will receive multi-layer thermoformed retainers...

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who have completed their active orthodontic treatment.
• Adults aged 18 years and above.
• Cooperative individuals willing to participate.
• Patients with good oral hygiene and general health.
• No systemic diseases that may affect treatment outcomes.

Exclusion criteria

• Smokers.
• Patients with a history of poor compliance with previous orthodontic treatment.
• Patients with parafunctional oral habits (e.g., bruxism).
• Patients undergoing retreatment due to relapse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

T1 - 3D-Printed Retainers

Experimental group

Description:

Participants in this group will receive retainers fabricated using direct 3D printing technology with bio-compatible clear resin.

Treatment:

Device: Direct 3D-Printed Retainer

T2 - Single-Layer Thermoformed Retainers

Active Comparator group

Description:

Retainers fabricated using thermoplastic sheets and a standard thermoforming machine.

Treatment:

Device: Single-Layer Thermoformed Retainer

T3 - Multi-Layer Thermoformed Retainers

Active Comparator group

Description:

Participants in this group will receive retainers fabricated using a multi-layer thermoforming method

Treatment:

Device: Multi-Layer Thermoformed Retainer