Orthodontic Retention ApplianceNCT07053410
Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers
A study testing Direct 3D-Printed Retainer, Single-Layer Thermoformed Retainer and Multi-Layer Thermoformed Retainer in people with Orthodontic Retention Appliance and Clear Orthodontic Retainers, run by Essraa hassan Hussein Mohamed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retention Appliance, Clear Orthodontic Retainers
- What is being tested?
- Direct 3D-Printed Retainer, Single-Layer Thermoformed Retainer and Multi-Layer Thermoformed Retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dental Medicine, Al-Azhar University - Assiut Branch
Asyut, Assuit, 71511
Essraa H. Mohamed, BDS, 00201159327869, Essraa_elaraby88@yahoo.com
About this study
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.
Read the 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…
- Being tested
- Direct 3D-Printed Retainer, Single-Layer Thermoformed Retainer, Multi-Layer Thermoformed Retainer
- Keywords
- Direct 3D-printed retainers, Multilayer retainer, Singlelayer retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct 3D-Printed RetainerDevice
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.
Single-Layer Thermoformed RetainerDevice
Clear orthodontic retainers fabricated by thermoforming a single-layer thermoplastic sheet over a 3D printed dental model using a vacuum forming machine.
Multi-Layer Thermoformed RetainerDevice
Orthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy.
| Study group | Role | What they receive |
|---|---|---|
| T1 - 3D-Printed Retainers | Experimental | Participants in this group will receive retainers fabricated using direct 3D printing technology with bio-compatible clear resin. Receives: Device: Direct 3D-Printed Retainer |
| T2 - Single-Layer Thermoformed Retainers | Active comparator | Retainers fabricated using thermoplastic sheets and a standard thermoforming machine. Receives: Device: Single-Layer Thermoformed Retainer |
| T3 - Multi-Layer Thermoformed Retainers | Active comparator | Participants in this group will receive retainers fabricated using a multi-layer thermoforming method Receives: Device: Multi-Layer Thermoformed Retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month after retainer delivery
Secondary outcomes (1)
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.
Measured: 1 month after retainer delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Retention ApplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel arms: 3D-printed retainers, single-layer thermoformed retainers, or multi-layer thermoformed retainers.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essraa hassan Hussein Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Essraa hassan Hussein Mohamed, Al-Azhar University
- Investigators
- Mostafa M. Dawaba, PhD, Principal investigator, Faculty of Dental Medicine, Al-Azhar University - Assiut Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053410
- Sponsor's protocol ID
- Orthodontic retainers
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dimensional Accuracy and Color Stability Between Direct 3D-printed and Thermoformed Retainers
- ClinicalTrials.gov ID
- NCT07053410
- Acronym / sponsor ID
- Orthodontic retainers
- Keywords
- Direct 3D-printed retainers, Multilayer retainer, Singlelayer retainer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Essraa hassan Hussein MohamedUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel arms: 3D-printed retainers, single-layer thermoformed retainers, or multi-layer thermoformed retainers.
| Arm | Type | Receives |
|---|---|---|
| T1 - 3D-Printed Retainers | Experimental | Device: Direct 3D-Printed RetainerParticipants in this group will receive retainers fabricated using direct 3D printing technology with bio-compatible clear resin. |
| T2 - Single-Layer Thermoformed Retainers | Active comparator | Device: Single-Layer Thermoformed RetainerRetainers fabricated using thermoplastic sheets and a standard thermoforming machine. |
| T3 - Multi-Layer Thermoformed Retainers | Active comparator | Device: Multi-Layer Thermoformed RetainerParticipants in this group will receive retainers fabricated using a multi-layer thermoforming method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct 3D-Printed RetainerOrthodontic 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 | T1 - 3D-Printed Retainers |
| Single-Layer Thermoformed RetainerClear orthodontic retainers fabricated by thermoforming a single-layer thermoplastic sheet over a 3D printed dental model using a vacuum forming machine. | Device | T2 - Single-Layer Thermoformed Retainers |
| Multi-Layer Thermoformed RetainerOrthodontic retainers fabricated using a multi-layer thermoforming technique combining different thermoplastic materials to enhance durability and fit accuracy. | Device | T3 - Multi-Layer Thermoformed Retainers |
Primary outcome
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).
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Orthodontic Retention Appliance, Orthodontic Relapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa M. Dawaba, PhD principal investigator
Faculty of Dental Medicine, Al-Azhar University - Assiut Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct 3D-Printed Retainer, Single-Layer Thermoformed Retainer and Multi-Layer Thermoformed Retainer in people with Orthodontic Retention Appliance and Clear Orthodontic Retainers, run by Essraa hassan Hussein Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Essraa H. Mohammed (00201159327869 ext. 002, Essraa_elaraby88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.