Biological Reaction of Direct 3d Printed Retainers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: retainer with .5 mm thickness, retainer with 1 mm thickness.
- Who it may be relevant to
- Registry conditions: Orthodontic Retainers. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers
Overview
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
Interventions
- Device retainer with .5 mm thickness
direct 3d printed retainer with .5 mm thickness - Device retainer with 1 mm thickness
direct 3d printed retainer with 1 mm thickness,
Primary outcome measures
- Bacterial growth measured using colony-forming unit (CFU) count on agar plates. [Time frame: 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. [Time frame: from day 0 (baseline time ) to 14 days after insertion]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dental Medicine , Al-Azhar University — Asyut
Identifiers
NCT: NCT07098325 · Direct 3d printed retainers