Biological response to directly 3D-printed orthodontic retainers
Official title: Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers
Run by Al-Azhar University · NCT07098325 · Data updated 2026-11-12
We will test whether 0.5 mm versus 1.0 mm thick directly 3D-printed retainers change bacterial growth and color in people who have just finished fixed braces.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | August 1, 2025 |
| Trial ID | NCT07098325 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people who have finished fixed orthodontic therapy, have good oral hygiene, do not smoke, and can follow written instructions.
✕Probably not a fit
Patients on medications that affect saliva, those with periodontitis or intrinsic tooth discoloration, or uncooperative individuals may not receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study will fit patients who completed fixed orthodontic treatment with directly 3D-printed clear retainers manufactured at two thicknesses (0.5 mm and 1.0 mm). Participants with good oral hygiene and no habits like smoking will be followed over time to measure bacterial colonization and color stability of the retainers. Primary outcomes are quantitative bacterial growth and objective color change; a secondary outcome is determining the optimal thickness for biological performance in clear aligner fabrication. Patients taking medications that affect saliva, with periodontitis, intrinsic tooth discoloration, or who cannot follow instructions will be excluded.
Why it matters
Potential benefit: If successful, this could identify a retainer thickness that reduces bacterial buildup and staining, improving hygiene and retainer longevity.
How similar studies have gone: Directly 3D-printed retainers are a recent innovation and studies specifically comparing thickness for bacterial growth and color are limited, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * -Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan. * Good oral hygiene. * No habits (e.g., smoking) Exclusion Criteria: * Medication affecting saliva. * intrinsic tooth discoloration. * Uncooperative patients. * Patient with periodontitis. * Learning difficulties and inability to read written instructions.
Where it's running
-
Faculty of Dental Medicine , Al-Azhar University
Asyut, Egypt Recruiting
Study contacts
- Study coordinator: Norhan Ibrahim Eldsokee Master's Candidate, B.D.S
- Email: noureldsokee@gmail.com
- Phone: +20 01559921144
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.