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临床试验/NCT06051487
NCT06051487已完成不适用

Evaluation of the Effect of Titanium Dioxide Nanoparticles Addition to Acrylic Baseplates of Orthodontic Functional Appliances

Mansoura University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Bacterial colony count

研究概览

简要总结

Background The objective of this study was to evaluate the antibacterial effect of Titanium dioxide nanoparticles incorporated into the acrylic baseplates of maxillary part of twin block appliances in orthodontic patients during the treatment period.

Material and methods Twenty-six patients were selected randomly and divided into two groups(n=13). Test group patients were used orthodontic functional appliances containing Titanium dioxide nanoparticles in acrylic baseplates. Control group patients were used orthodontic functional appliances without Titanium dioxide nanoparticles in acrylic baseplates. Swap samples were taken from palatal gingiva facing fitting surface of acrylic component of maxillary part of twin block appliance for each patient at five times intervals (base line sample, after one, two, four, and six months) then cultured in blood agar plates to calculate bacterial colony count.

详细描述

Design of the appliance

For all of the chosen patients, the Twin Block, which consists of upper and lower bite blocks, was constructed. In this study the upper bite block was used. The upper part incorporates labial bow with U loop around canines and Adam clasps on the upper first molars for retention. Midline screw may be added to the upper part of the appliance to aid in the correction of the posterior cross bite if occurred during treatment.

Appliance construction (dental laboratory step) Based on cast models of each patient, acrylic baseplates for orthodontic appliances were manufactured using auto-polymerizing PMMA resin, the monomer-to-polymer ratio recommended by the manufacturer, and standard acrylization, trimming, and finishing-polishing processes The acrylic material used for fabrication of the appliance was (Acrostone acrylic material, under exclusive liscence, England). The manufacturer's suggested powder-liquid volume ratio is 3:1 representing 22 g of the polymer and 10 mL of the liquid monomer. Powder-liquid volume ratio for construction of appliance was calculated . This created samples were the control group.

Intervention Titanium dioxide nano powder was prepared at City of Scientific Research and Technological Applications (SRTA-City) in Egypt.

During the appliance containing TiO2 nanoparticles construction, first of all, the calculated quantity of titanium dioxide nano powder was mixed manually with acrylic resin polymer for 60 s by shaking the powders inside a small container and subsequently, the calculated quantity of the monomer was added to obtain a PMMA containing TiO2 NPs .This created samples were the test group. the powder was mixed with the liquid as recommended by the manufacturer, applied to a mold and flasked. Then the acrylic baseplate was finished and polished.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • early permanent dentition (ages 9 to 14)
  • mandibular retrusion-related class II skeletal deformity
  • overjet more than 4mm

排除标准

  • systemic diseases
  • congenital craniofacial deformity
  • inflammatory or infectious diseases within the previous month
  • taking medication in the last month, such as fluoride or antibiotics
  • frequent consumers of sorbitol- and xylitol-containing products
  • mouth rinses
  • unusual or specific dietary habits
  • cleft lip or palate
  • unusual habits or previous orthodontic treatment.

结局指标

主要结局

Bacterial colony count

时间窗: samples was taken within five time intervals (base line samples, at one month, at two months, at four months, at six months)

Changes in bacterial colony count under acrylic base plate in Participants using twin block appliance containing titanium dioxide nanoparticles in comparison to participant using appliance not containing titanium dioxide nanoparticles

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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