Orthodontic RetainersNCT07098325
Biological Reaction of Direct 3d Printed Retainers
A study testing retainer with .5 mm thickness and retainer with 1 mm thickness in people with Orthodontic Retainers, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study will be to evaluate the biological reaction of direct three dimensional printed retainers. Primary objective is to evaluate bacterial growth and color stability between different thicknesses of 3d printed material used as a retainer . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthodontic Retainers
- What is being tested?
- retainer with .5 mm thickness and retainer with 1 mm thickness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Jun 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.
- Good oral hygiene.
- No habits (e.g., smoking)
Who cannot join
- Medication affecting saliva.
- intrinsic tooth discoloration.
- Uncooperative patients.
- Patient with periodontitis.
- Learning difficulties and inability to read written instructions.
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, 1 recruiting
- Recruiting
Faculty of Dental Medicine , Al-Azhar University
Asyut
About this study
Official title: Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers
The aim of this study will be to evaluate the biological reaction of direct three dimensional printed retainers.
Primary objective is to evaluate bacterial growth and color stability between different thicknesses of 3d printed material used as a retainer .
Secondary objective is to determine the optimal thickness for use in clear aligner fabrication based on biological performance.
Read the detailed description
Retainers are routinely fitted at the end of active orthodontic treatment to allow the teeth to adjust to their new positions The growing demand has led to constant improvements in materials and technologies offered by a rising number of different companies.
In recent years, major technological innovations in 3D printing, especially related to computer-aided design, biomaterials and manufacturing techniques, have enabled the production of in-office direct printed Retainers (DPRs) - representing an innovation compared to the traditional thermoformed Retainers.
Insufficient cleaning will lead to microbe's growth in retainers. The mostly found microbes are candida and staphylococcus that may include MRSA strains. Once the biofilms are formed in the retainer it's quite difficult to remove that biofilm which shows resistance to antimicrobials and difficult to clear.
orthodontic retainers hinder the sterilizing effect of saliva, which further promotes the rapid division, reproduction, and growth of colonized bacteria.
Staphylococcus aureus is most commonly found on the retainers and tends to cause bloodstream infections which can lead to serious other infections.
While several studies have assessed tooth movement, and biomechanical and clinical effects according to the design of attachments, studies investigating the thickness of the CAs are limited
- Conditions
- Orthodontic Retainers
- Being tested
- retainer with .5 mm thickness, retainer with 1 mm thickness
- Keywords
- Different thicknesses, Direct three dimensional printed retainers, Bacterial growth, Color change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retainer with .5 mm thicknessDevice
direct 3d printed retainer with .5 mm thickness
retainer with 1 mm thicknessDevice
direct 3d printed retainer with 1 mm thickness,
| Study group | Role | What they receive |
|---|---|---|
| direct 3d printed retainer of .5mm | Experimental | group wearing direct 3d retainer of .5 mm Receives: Device: retainer with .5 mm thickness |
| direct 3d printed retainer of 1mm | Experimental | group wearing direct 3 d retainer with thickness 1 mm Receives: Device: retainer with 1 mm thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial growth measured using colony-forming unit (CFU) count on agar plates.
Saliva samples will be collected from each participant at baseline and at day 14. Samples will be cultured on standard agar plates under aerobic conditions. After incubation, bacterial colonies will be counted, and results will be expressed in colony-forming units per milliliter (CFU/ml). A higher CFU value indicates greater bacterial growth.
Units:
CFU/ml
Measured: from day 0 (Baseline time ) to 14 days after insertion
Color change of 3D printed retainers measured using spectrophotometer; ΔE calculated at day 0 and day 14.
The color stability of the retainers will be assessed using a spectrophotometer (VITA Easyshade or equivalent). Color difference (ΔE) will be calculated between baseline and day 14. A ΔE > 3.3 is considered clinically perceptible. Scale range: 0-10; higher ΔE score indicates greater color change and worse color stability.
Units:
ΔE (Delta E) score
Measured: from day 0 (baseline time ) to 14 days after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RetainersStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Ibrahim Eldsokee Khidr, Al-Azhar University
- Investigators
- Dr. Mustafa Mohamed Mahmoud Dawaba Associate Professor of Orthodontics, Study chair, Faculty of Dental Medicine, Al-Azhar University Assiut BranchDr. Mahmoud Mohamed Salah El-din Ibrahim Lecturer of Orthodontics, Study chair, Faculty of Dental Medicine , Al-Azhar University Assiut Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098325
- Sponsor's protocol ID
- Direct 3d printed retainers
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers
- ClinicalTrials.gov ID
- NCT07098325
- Acronym / sponsor ID
- Direct 3d printed retainers
- Conditions
- Orthodontic Retainers
- Keywords
- Different thicknesses, Direct three dimensional printed retainers, Bacterial growth, Color change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Aug 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.
The aim of this study will be to evaluate the biological reaction of direct three dimensional printed retainers.
Primary objective is to evaluate bacterial growth and color stability between different thicknesses of 3d printed material used as a retainer .
Secondary objective is to determine the optimal thickness for use in clear aligner fabrication based on biological performance.
Detailed description
Retainers are routinely fitted at the end of active orthodontic treatment to allow the teeth to adjust to their new positions The growing demand has led to constant improvements in materials and technologies offered by a rising number of different companies.
In recent years, major technological innovations in 3D printing, especially related to computer-aided design, biomaterials and manufacturing techniques, have enabled the production of in-office direct printed Retainers (DPRs) - representing an innovation compared to the traditional thermoformed Retainers.
Insufficient cleaning will lead to microbe's growth in retainers. The mostly found microbes are candida and staphylococcus that may include MRSA strains. Once the biofilms are formed in the retainer it's quite difficult to remove that biofilm which shows resistance to antimicrobials and difficult to clear.
orthodontic retainers hinder the sterilizing effect of saliva, which further promotes the rapid division, reproduction, and growth of colonized bacteria.
Staphylococcus aureus is most commonly found on the retainers and tends to cause bloodstream infections which can lead to serious other infections.
While several studies have assessed tooth movement, and biomechanical and clinical effects according to the design of attachments, studies investigating the thickness of the CAs are limited
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct 3d printed retainer of .5mm | Experimental | Device: retainer with .5 mm thicknessgroup wearing direct 3d retainer of .5 mm |
| direct 3d printed retainer of 1mm | Experimental | Device: retainer with 1 mm thicknessgroup wearing direct 3 d retainer with thickness 1 mm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- -Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.
- Good oral hygiene.
- No habits (e.g., smoking)
Key exclusion criteria (5 listed)
- Medication affecting saliva.
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 |
|---|---|---|
| retainer with .5 mm thicknessdirect 3d printed retainer with .5 mm thickness | Device | direct 3d printed retainer of .5mm |
| retainer with 1 mm thicknessdirect 3d printed retainer with 1 mm thickness, | Device | direct 3d printed retainer of 1mm |
Primary outcome
Bacterial growth measured using colony-forming unit (CFU) count on agar plates.
Time frame: from day 0 (Baseline time ) to 14 days after insertion
Saliva samples will be collected from each participant at baseline and at day 14. Samples will be cultured on standard agar plates under aerobic conditions. After incubation, bacterial colonies will be counted, and results will be expressed in colony-forming units per milliliter (CFU/ml). A higher CFU value indicates greater bacterial growth. Units: CFU/ml
Color change of 3D printed retainers measured using spectrophotometer; ΔE calculated at day 0 and day 14.
Time frame: from day 0 (baseline time ) to 14 days after insertion
The color stability of the retainers will be assessed using a spectrophotometer (VITA Easyshade or equivalent). Color difference (ΔE) will be calculated between baseline and day 14. A ΔE > 3.3 is considered clinically perceptible. Scale range: 0-10; higher ΔE score indicates greater color change and worse color stability. Units: ΔE (Delta E) score
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 1 Aug 2025.
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Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
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3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
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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.
Dr. Mustafa Mohamed Mahmoud Dawaba Associate Professor of Orthodontics study chair
Faculty of Dental Medicine, Al-Azhar University Assiut Branch
Dr. Mahmoud Mohamed Salah El-din Ibrahim Lecturer of Orthodontics study chair
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 retainer with .5 mm thickness and retainer with 1 mm thickness in people with Orthodontic Retainers, run by Al-Azhar 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: looking for participants now, as of the sponsor's last update on 1 Aug 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 Norhan Ibrahim Eldsokee Master's Candidate, B.D.S (+20 01559921144, noureldsokee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial growth measured using colony-forming unit (CFU) count on agar plates. (time frame: from day 0 (Baseline time ) to 14 days after insertion). The study lists 2 primary outcomes in all. 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 1 Aug 2025.