Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Direct 3D-Printed Retainer, Single-Layer Thermoformed Retainer, Multi-Layer Thermoformed Retainer.
- Who it may be relevant to
- Registry conditions: Orthodontic Retention Appliance, Clear Orthodontic Retainers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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…
Interventions
- Device 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. - 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. - Device Multi-Layer Thermoformed Retainer
Orthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy.
Primary outcome measures
- Mean Surface Deviation (mm) Between Retainer STL and Original STL Reference Model Assessed by 3D Superimposition After 1 Month [Time frame: 1 month after retainer delivery]
Secondary outcome measures (1)
- Color Change (ΔE) of Retainers Measured by Spectrophotometer Based on CIE L*a*b* System After 1 Month [Time frame: 1 month after retainer delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dental Medicine, Al-Azhar University - Assiut Branch — Asyut
Identifiers
NCT: NCT07053410 · Orthodontic retainers