Biological Reaction of Direct 3d Printed Retainers

Официальное название

Evaluation of Biological Reaction of Direct Three Dimensional Printed Retainers

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство retainer with .5 mm thickness
  direct 3d printed retainer with .5 mm thickness
• Устройство retainer with 1 mm thickness
  direct 3d printed retainer with 1 mm thickness,

Первичные конечные точки

• Bacterial growth measured using colony-forming unit (CFU) count on agar plates. [Срок оценки: 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. [Срок оценки: from day 0 (baseline time ) to 14 days after insertion]

Критерии участия

Критерии включения

• -Finished fixed orthodontic therapy and seeking for retention as a part of their original treatment plan.
• Good oral hygiene.
• No habits (e.g., smoking)

Критерии исключения

• Medication affecting saliva.

• intrinsic tooth discoloration.
• Uncooperative patients.
• Patient with periodontitis.
• Learning difficulties and inability to read written instructions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dental Medicine , Al-Azhar University — Asyut

Идентификаторы

NCT: NCT07098325 · Direct 3d printed retainers

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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