Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean Surface Deviation (mm) Between Retainer STL and Original STL Reference Model Assessed by 3D Superimposition After 1 Month
Study Overview
Brief Summary
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...
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
T1 - 3D-Printed Retainers
Participants in this group will receive retainers fabricated using direct 3D printing technology with bio-compatible clear resin.
Intervention: Direct 3D-Printed Retainer (Device)
T2 - Single-Layer Thermoformed Retainers
Retainers fabricated using thermoplastic sheets and a standard thermoforming machine.
Intervention: Single-Layer Thermoformed Retainer (Device)
T3 - Multi-Layer Thermoformed Retainers
Participants in this group will receive retainers fabricated using a multi-layer thermoforming method
Intervention: Multi-Layer Thermoformed Retainer (Device)
Outcomes
Primary Outcomes
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
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).
Secondary Outcomes
- Color Change (ΔE) of Retainers Measured by Spectrophotometer Based on CIE L*a*b* System After 1 Month(1 month after retainer delivery)
Investigators
Essraa hassan Hussein Mohamed
Master's Degree Candidate in Orthodontics
Al-Azhar University