Faculty of Dental Medicine , Al-Azhar University
Asyut, Egypt
Location status: Recruiting
NCT Number: NCT07098325
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.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Asyut, Egypt
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
direct 3d printed retainer with .5 mm thickness
direct 3d printed retainer with 1 mm thickness,
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
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
Contact information is provided by the study sponsor or research team.
Al-Azhar University
Other
Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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