Biological Reaction of Direct 3d Printed Retainers
ConditionOrthodontic Retainers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAl-Azhar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.
Good oral hygiene.
No habits (e.g., smoking)
Disqualifiers
Medication affecting saliva.
intrinsic tooth discoloration.
Uncooperative patients.
Patient with periodontitis.
Trial design
Design model
Parallel
Treatments tested in this trial
retainer with .5 mm thickness
Devicedirect 3d printed retainer with .5 mm thickness
retainer with 1 mm thickness
Devicedirect 3d printed retainer with 1 mm thickness,
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: direct 3d printed retainer of .5mmExperimental treatment 1 intervention
Group B: direct 3d printed retainer of 1mmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
from day 0 (Baseline time ) to 14 days after insertion2
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
Time frame
from day 0 (baseline time ) to 14 days after insertionSponsors and contacts
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Source ClinicalTrials.gov