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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.
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…
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1 - 3D-Printed Retainers | Experimental | Participants in this group will receive retainers fabricated using direct 3D printing technology with bio-compatible clear resin. |
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| T2 - Single-Layer Thermoformed Retainers | Active Comparator | Retainers fabricated using thermoplastic sheets and a standard thermoforming machine. |
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| T3 - Multi-Layer Thermoformed Retainers | Active Comparator | Participants in this group will receive retainers fabricated using a multi-layer thermoforming method |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct 3D-Printed Retainer | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Surface Deviation (mm) Between Retainer STL and Original STL Reference Model Assessed by 3D Superimposition After 1 Month | Dimensional accuracy will be assessed by scanning each retainer and generating an STL file. The resulting STL will be superimposed on the original digital reference STL model using best-fit alignment in 3D inspection software (e.g., Geomagic Control X). The software will calculate the mean surface deviation in millimeters (mm). Results will be reported as mean ± standard deviation for each group (3D-printed vs thermoformed). | 1 month after retainer delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Color Change (ΔE) of Retainers Measured by Spectrophotometer Based on CIE L*a*b* System After 1 Month | Color stability will be evaluated by measuring the color of each retainer before and after intraoral use using a spectrophotometer. The color change (ΔE) will be calculated according to the CIE L*a*b* color system formula. Results will be reported as mean ΔE ± standard deviation for each group. A ΔE value >3.3 will be considered visually perceptible. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Essraa H. Mohammed | Contact | 00201159327869 | 002 | Essraa_elaraby88@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mostafa M. Dawaba, PhD | Faculty of Dental Medicine, Al-Azhar University - Assiut Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental Medicine, Al-Azhar University - Assiut Branch | Asyut | Assuit | 71511 | Egypt |
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Participants will be randomly assigned to one of three parallel arms: 3D-printed retainers, single-layer thermoformed retainers, or multi-layer thermoformed retainers.
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| Single-Layer Thermoformed Retainer | Device | Clear orthodontic retainers fabricated by thermoforming a single-layer thermoplastic sheet over a 3D printed dental model using a vacuum forming machine. |
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| Multi-Layer Thermoformed Retainer | Device | Orthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy. |
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| 1 month after retainer delivery |