Orthodontic Retainers3DNCT07916012
3D Printed Orthodontic Retainers
A study testing 3d printed retainers, positive pressure thermoformed retainers and vacuum pressure thermoformed retainers in people with Orthodontic Retainers, run by Ain Shams University at 1 site in Egypt.
Trial summary
comparison between clinical performance and patient satisfaction of directly printed and thermoformed orthodontic retainers Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Orthodontic Retainers
- What is being tested?
- 3d printed retainers, positive pressure thermoformed retainers and vacuum pressure thermoformed retainers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 28 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Full complement of permanent teeth except third molars.
- Well aligned and finished arches (defined as zero Little's Irregularity Index, normal overjet and overbite on debonding day).
- Patients requiring basic clear retainer design. (No splints, advancing steps, attachments, etc...)
Who cannot join
- Patients not willing to use removable retainers or indicated for bonded retainers.
- Patients with biting habits (clinching, bruxism, etc.…)
- Patients with poor oral hygiene or gingival inflammation.
- Patients in whom rapid arch expansion/orthognathic surgery was performed.
- Patients with hypodontia, cleft lip palate/ craniofacial anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Directly 3D Printed and Thermoformed Orthodontic Retainers
comparison between clinical performance and patient satisfaction of directly printed and thermoformed orthodontic retainers
Read the detailed description
A sample of adult patients who met the inclusion criteria signed an informed consent after full explanation of the study procedure.
Directly after debonding maxillary arches of all patients were scanned using an intra-oral scanner and were randomly allocated into 3 groups using computer software.
Directly 3D printed orthodontic retainers group:
1-The digital models obtained from the scans were used for designing the retainer shells using DAD software for the patients. 2-The stl files of the designed retainers were 3D printed using specific retainer resin material and compatible 3D printer according to manufacturer instructions. 3- The printed retainers were cleaned from excess resin material and post-cured according to manufacturer instructions.4- The printed retainers were delivered to patients and conventional instructions for use of clear retainers were explained.
Thermoformed orthodontic retainers groups:
1- models were used for fabricating thermoformed orthodontic retainers.2- Sheets compatible with positive pressure and vacuum press thermoforming machines were used to produce two groups of thermoformed orthodontic retainers according to manufacturer instructions.3- The produced thermoformed retainers were also delivered to patients and conventional instructions for use of clear retainers were explained.
Patients were scheduled for follow up visit 6 months after retainers delivery in which intra-oral scanning. comparison between original and follow up scans was done.
- study setting :This study was conducted in the Orthodontic Department and the Orthodontic Digital Centre of the Faculty of Dentistry, Ain Shams University and the Innovative Digital Centre of the Faculty of Dentistry, the British University in Egypt.
- Statistical analysis: comparison between original and follow up scans was done using computer software.
- Conditions
- Orthodontic Retainers
- Being tested
- 3d printed retainers, positive pressure thermoformed retainers, vacuum pressure thermoformed retainers
- Keywords
- retainers, direct printing, 3 dimensional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed retainersDevice
3d printed retainers were constructed and delivered to the patients after orthodontic treatment
positive pressure thermoformed retainersDevice
positive pressure thermoformed retainers were constructed and delivered to the patients after orthodontic treatment
vacuum pressure thermoformed retainersDevice
vacuum pressure thermoformed retainers were constructed and delivered to the patients after orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Directly 3D printed orthodontic retainers | Experimental | photopolymer resin material was used for direct printing of orthodontic retainers Receives: Device: 3d printed retainers |
| positive-pressure thermoformed retainers | Experimental | orthodontic thermoforming sheets were used for positive-pressure fabrication of orthodontic retainers Receives: Device: positive pressure thermoformed retainers |
| vacuum-pressure thermoformed retainers | Active comparator | orthodontic thermoforming sheets were used for vacuum-pressure fabrication of orthodontic retainers Receives: Device: vacuum pressure thermoformed retainers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness
comparing clinical effectiveness of directly 3D printed retainers vs thermoformed retainers fabricated by both positive and vacuum-pressure techniques was done using Geomagic software measurement of ( Little's irregularity index , inter-molar, inter-canine widths) between original and follow up scans. unit for all variables measured was mm.
Measured: 6 months
Secondary outcomes (1)
patient satisfaction
comparing directly 3D printed retainers vs thermoformed retainers fabricated by both positive and vacuum-pressure techniques regarding patient satisfaction was done through visual analogue questionnaire on both day of delivery and follow up visit after 6 months. The questionnaire consisted of the following questions: Q1 Do you find your retainer comfortable? Q2 Do you like your retainer colour? Q3 Does the retainer have any weird taste? Q4 Does the retainer affect your speech?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start20 Apr 2022
- Primary completion20 Jul 2024
- Study completion28 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic RetainersStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hala diraz, Ain Shams University
- Investigators
- Hala Magdy Diraz, Lecturer, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916012
- Sponsor's protocol ID
- 3D printing
- Acronym
- 3D
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: patient age satisfaction
Publications
Devi, S. & Jain, R. K. Comparison of Retention Characteristics of Clear bow Hawley's and Vacuum Formed Retainers - A Randomized Controlled Trial. J Orofac Sci 14, 128-133 (2022).
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Directly 3D Printed and Thermoformed Orthodontic Retainers
- ClinicalTrials.gov ID
- NCT07916012
- Acronym / sponsor ID
- 3D / 3D printing
- Conditions
- Orthodontic Retainers
- Keywords
- retainers, direct printing, 3 dimensional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 28 Sep 2025 (actual)
- First posted
- 4 Nov 2026 (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.
comparison between clinical performance and patient satisfaction of directly printed and thermoformed orthodontic retainers
Detailed description
A sample of adult patients who met the inclusion criteria signed an informed consent after full explanation of the study procedure.
Directly after debonding maxillary arches of all patients were scanned using an intra-oral scanner and were randomly allocated into 3 groups using computer software.
Directly 3D printed orthodontic retainers group:
1-The digital models obtained from the scans were used for designing the retainer shells using DAD software for the patients. 2-The stl files of the designed retainers were 3D printed using specific retainer resin material and compatible 3D printer according to manufacturer instructions. 3- The printed retainers were cleaned from excess resin material and post-cured according to manufacturer instructions.4- The printed retainers were delivered to patients and conventional instructions for use of clear retainers were explained.
Thermoformed orthodontic retainers groups:
1- models were used for fabricating thermoformed orthodontic retainers.2- Sheets compatible with positive pressure and vacuum press thermoforming machines were used to produce two groups of thermoformed orthodontic retainers according to manufacturer instructions.3- The produced thermoformed retainers were also delivered to patients and conventional instructions for use of clear retainers were explained.
Patients were scheduled for follow up visit 6 months after retainers delivery in which intra-oral scanning. comparison between original and follow up scans was done.
- study setting :This study was conducted in the Orthodontic Department and the Orthodontic Digital Centre of the Faculty of Dentistry, Ain Shams University and the Innovative Digital Centre of the Faculty of Dentistry, the British University in Egypt.
- Statistical analysis: comparison between original and follow up scans was done using computer software.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Directly 3D printed orthodontic retainers | Experimental | Device: 3d printed retainersphotopolymer resin material was used for direct printing of orthodontic retainers |
| positive-pressure thermoformed retainers | Experimental | Device: positive pressure thermoformed retainersorthodontic thermoforming sheets were used for positive-pressure fabrication of orthodontic retainers |
| vacuum-pressure thermoformed retainers | Active comparator | Device: vacuum pressure thermoformed retainersorthodontic thermoforming sheets were used for vacuum-pressure fabrication of orthodontic retainers |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full complement of permanent teeth except third molars.
- Well aligned and finished arches (defined as zero Little's Irregularity Index, normal overjet and overbite on debonding day).
- Patients requiring basic clear retainer design. (No splints, advancing steps, attachments, etc...)
Key exclusion criteria (5 listed)
- Patients not willing to use removable retainers or indicated for bonded retainers.
- Patients with biting habits (clinching, bruxism, etc.…)
- Patients with poor oral hygiene or gingival inflammation.
- Patients in whom rapid arch expansion/orthognathic surgery was performed.
- Patients with hypodontia, cleft lip palate/ craniofacial anomalies.
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 |
|---|---|---|
| 3d printed retainers3d printed retainers were constructed and delivered to the patients after orthodontic treatment | Device | Directly 3D printed orthodontic retainers |
| positive pressure thermoformed retainerspositive pressure thermoformed retainers were constructed and delivered to the patients after orthodontic treatment | Device | positive-pressure thermoformed retainers |
| vacuum pressure thermoformed retainersvacuum pressure thermoformed retainers were constructed and delivered to the patients after orthodontic treatment | Device | vacuum-pressure thermoformed retainers |
Primary outcome
Clinical effectiveness
Time frame: 6 months
comparing clinical effectiveness of directly 3D printed retainers vs thermoformed retainers fabricated by both positive and vacuum-pressure techniques was done using Geomagic software measurement of ( Little's irregularity index , inter-molar, inter-canine widths) between original and follow up scans. unit for all variables measured was mm.
1 secondary outcome
patient satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundDevi, S. & Jain, R. K. Comparison of Retention Characteristics of Clear bow Hawley's and Vacuum Formed Retainers - A Randomized Controlled Trial. J Orofac Sci 14, 128-133 (2022).
- Individual participant dataSharing planned: Yes. patient age satisfaction
Related trials for Orthodontic Retainers
Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Not yet recruiting
Digital vs Conventional VFR in Post-Orthodontic Retention
Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)
Active, not recruiting
Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
Dental Malocclusion, Stability
Not yet recruiting
3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
Orthodontic Relapse, Malocclusion
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
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. This study is not recruiting at the moment.
Hala Magdy Diraz, Lecturer principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed retainers, positive pressure thermoformed retainers and vacuum pressure thermoformed retainers in people with Orthodontic Retainers, run by Ain Shams University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effectiveness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07916012, which also lists 1 linked publication.
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 4 Nov 2026.