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Набор по приглашению NCT07672847

Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate and Polyether Ether Ketone Denture Base Materials

Без фазы С лечением Denture CAD/CAM Stability PEEK

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: M0 group, M1 group : PMMA+ Sodium hypochlorite, M2 group: PMMA+ Chlorhexidine, M3 group : PMMA + Effervescent Alkaline Peroxide Tablet.
Кому может быть актуально
Состояния в реестре: Denture, CAD/CAM, Stability, PEEK. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate (PMMA) and Polyether Ether Ketone (PEEK) Denture Base Materials: An In Vitro Study

Обзор

This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.

Подробное описание

Dentures are custom-made medical devices prescribed by dentists and clinical dental technicians to replace oral hard and soft tissue structures. Dentures consist of the denture base and denture teeth. Denture bases can be fabricated using acrylic (polymethylmethacrylate \[PMMA\]), metal alloys (cobalt-chromium) and polymers, such as nylon-based thermoplastic resins, polyether ether ketone \[PEEK\] and aryl ketone polymer. Heat-cured PMMA is the most commonly used denture base; this is inherently porous, non shedding and readily aggregates denture plaque. Denture teeth can be fabricated from acrylic, composite resin, or porcelain as these are significantly smoother surfaces; however, denture plaque can grow around the 'tooth-gingivae' interface, which represents the interface between the denture teeth and pink resin of the denture, representing the gingival tissue.

Denture plaque contains pathogenic microbes including, Candida albicans (linked with denture stomatitis) and Streptococcus mutans (linked with caries development). Methicillin resistant Staphylococcus aureus has been previously isolated from denture patients in general practice and the general hospital setting; however, it is unknown whether cross contamination or infection can occur when handling dentures. Most patients exhibit poor denture hygiene due to inadequate knowledge of optimal/correct cleaning techniques1 and a lack of standardization in denture hygiene assessments; dentists infrequently assess and record patients' denture hygiene status. Poor denture hygiene leads to increased risk of dental caries, periodontal disease, denture stomatitis and halitosis. Improper denture care negatively impacts denture clinical longevity and increases denture plaque aggregation. For example, scratches due to improper brushing technique, such as brushing with too hard a brush, can increase microbial growth, while inappropriate denture cleaner use can permanently damage a denture beyond clinical use. A working knowledge of denture base/tooth materials and denture cleaning methods should ensure optimal denture cleanliness without compromising material integrity and clinical longevity. Therefore, clinician-assisted patient education can improve patients' denture hygiene. The dental team is best suited to help provide patients with the necessary oral and denture hygiene education. The incorporation of CAD/CAM technology into complete denture design and fabrication streamlines the clinical and laboratory processes and provides improved physical properties that enhance denture quality. Studies have shown that CAD-CAM milled resins typically outperform 3D-printed materials in thermal stress resistance. Also, surface properties such as roughness, microhardness, and color stability are crucial determinants of durability and patient satisfaction. For instance, rougher surfaces can promote microbial adhesion, leading to biofilm formation and staining, while smoother, harder surfaces resist wear and microbial colonization. CAD-CAM milled PMMA showed significantly less C adherence. 3 and superior dimensional accuracy and stability compared with 3D printing and conventional methods. It remains the superior choice for long-term denture durability due to its high mechanical strength and wear resistance.

This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.

Вмешательства

  • Другое M0 group
    Immersed in distilled water at 37 c for 6 months
  • Другое M1 group : PMMA+ Sodium hypochlorite
    Immersed in 1% sodium hypochlorite solution for 6 months
  • Другое M2 group: PMMA+ Chlorhexidine
    Immersed in 0.2% chlorhexidine solution for 6 months
  • Другое M3 group : PMMA + Effervescent Alkaline Peroxide Tablet
    Immersed in Effervescent tablet denture cleanser solution for 6 months
  • Другое E0 group : PEEK control group
    Immersed in distilled water at 37 c for 6 months
  • Другое E1 group : PEEK + Sodium hypochlorite
    Immersed in 1% sodium hypochlorite solution for 6 months
  • Другое E2 group : PEEK +Chlorhexidine group
    Immersed in 0.2% chlorhexidine solution for 6 months
  • Другое E3 group: PEEK + Effervescent Alkaline Peroxide Tablet
    Immersed in Effervescent tablet denture cleanser solution for 6 months

Первичные конечные точки

  • Surface Roughness Measurement [Срок оценки: 6 months]
Вторичные конечные точки (1)
  • Microhardness Evaluation [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Used prefabricated CAD-CAM blocks (PMMA and PEEK, dental grade)
  • All specimens milled using standardized CAD-CAM protocols
  • Materials from same brand, batch and shade per group
  • All specimens polished to a clinical high gloss standard
  • Used standardized specimen geometry

Критерии исключения

  • Specimens fabricated using a method other than CAD-CAM milling
  • Use blocks from different manufacturer, batches or shades within the same test group
  • Use specimens with fabrication defects (visible porosity, cracks, internal voids) or obvious milling errors (tool chattering marks, incomplete milling)
  • Specimens with dimensional inaccuracy
  • Specimens subjected to incorrect immersion time, temp or concentration of disinfectant
  • Use contaminated, not freshly prepared or expired disinfectant solutions

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
Другое

Центры проведения

Египет · 1 центр
  • Menoufia University — Shibīn al Kawm

Идентификаторы

NCT: NCT07672847 · DP-01-26-106

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗