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

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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…

Conditions

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Orthodontic Retention Appliance Clear Orthodontic Retainers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of three parallel arms: 3D-printed retainers, single-layer thermoformed retainers, or multi-layer thermoformed retainers.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T1 - 3D-Printed Retainers

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

Group Type EXPERIMENTAL

Direct 3D-Printed Retainer

Intervention Type DEVICE

Orthodontic retainers fabricated using direct 3D printing technology from digital STL models. The retainers are printed with biocompatible clear resin using an additive manufacturing process.

T2 - Single-Layer Thermoformed Retainers

Retainers fabricated using thermoplastic sheets and a standard thermoforming machine.

Group Type ACTIVE_COMPARATOR

Single-Layer Thermoformed Retainer

Intervention Type DEVICE

Clear orthodontic retainers fabricated by thermoforming a single-layer thermoplastic sheet over a 3D printed dental model using a vacuum forming machine.

T3 - Multi-Layer Thermoformed Retainers

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

Group Type ACTIVE_COMPARATOR

Multi-Layer Thermoformed Retainer

Intervention Type DEVICE

Orthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy.

Interventions

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Direct 3D-Printed Retainer

Orthodontic retainers fabricated using direct 3D printing technology from digital STL models. The retainers are printed with biocompatible clear resin using an additive manufacturing process.

Intervention Type DEVICE

Single-Layer Thermoformed Retainer

Clear orthodontic retainers fabricated by thermoforming a single-layer thermoplastic sheet over a 3D printed dental model using a vacuum forming machine.

Intervention Type DEVICE

Multi-Layer Thermoformed Retainer

Orthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes