Biological Reaction of Direct 3d Printed Retainers

Al-Azhar University

Status: Enrolling

Conditions: Orthodontic Retainers

Treatments: Device: retainer with 1 mm thickness; Device: retainer with .5 mm thickness

Study type: Interventional

Funder types: Other

Identifiers

NCT07098325

Direct 3d printed retainers

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

direct 3d printed retainer of .5mm

Experimental group

Description:

group wearing direct 3d retainer of .5 mm

Treatment:

Device: retainer with .5 mm thickness

direct 3d printed retainer of 1mm

Experimental group

Description:

group wearing direct 3 d retainer with thickness 1 mm

Treatment:

Device: retainer with 1 mm thickness