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临床试验/NCT04793503
NCT04793503已完成不适用

Biting Force and Chewing Efficiency of Conventional and CAD/CAM Complete Dentures: A Cross-over Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
biting force

研究概览

简要总结

The aim of this study was to compare the MBF and chewing efficiency of complete denture bases fabricated by conventional, 3D printing and milling techniques. The research hypothesis was that, there are no significant differences in MBF and chewing efficiency in complete dentures fabricated by the three methods.

详细描述

Participant selection and treatment This study will include a clinical experiment with a cross-over clinical trial design. For this study, 27completely edentulous participants with age range of 50-65 were selected from the outpatient clinic of the Removable Prosthodontic Department, Faculty of dentistry, Kafr Elsheikh University, Egypt. All participants had Angle class I jaw relation maxillomandibular relationship, normal alveolar ridge volume, no temporomandibular joint disorders, no heart disease, and no systemic diseases that affect the complete denture treatment procedures.

To reduce the effect of order of treatment on MBF, were successively given the following prosthesis i) complete dentures fabricated by the conventional technique ii) 3D printed complete dentures iii) milled complete dentures in a random order.

Construction of the CADCAM 3D printed denture The same steps of the conventional technique will be performed till the adjustment of occlusion rims then in the dental laboratory, the maxillary and mandibular definitive casts and the occlusal rims will be prepared for scanning with scan spray. Scanning will be performed with an optical 3D scanner . The files from the laser-scan will be translated into stereolithography (STL) files and the CDs are virtually designed in ExoCad software. After minor modifications in the positions of teeth were made, fabrication of the dentures will be approved and the digital denture base will be fabricated using 3D printing technique from Dental Pink resin

Construction of the CAD/CAM milled denture Once the complete denture has been virtually designed in CAD software (ExoCad software) a preview will be sent for evaluation using 3D viewing software. After minor modifications in the positions of teeth were made, fabrication of the dentures will be approved. The digital denture will be fabricated by the command software of the milling machine (ExoCad 5x milling machine) from prepolymerized resin acrylic pucks and the teeth (TSM Acetal Dental) were milled into template .After that the denture will be finished and polished according to the traditional procedures For all groups, after placement, clinical evaluations of the fit, retention, stability, occlusal relationship, esthetics, and phonetics were performed. Assessment of the occlusion was made with articulating paper, chairside adjustments were made and premature contacts were corrected. The patient was given a proper program for denture insertion and oral hygiene measures.

Assessment of biting force

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

the patient doesn't recognise the type of complete denture that he use

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Angle class I jaw relation maxillomandibular relationship
  • •Normal alveolar ridge volume
  • •No temporomandibular joint disorders
  • •No heart disease
  • •No systemic diseases that affect the complete denture treatment procedures

排除标准

  • •Abnormal jaw relation
  • •TMJ disorders
  • •Any systemic disease interfering with complete denture treatment

研究组 & 干预措施

conventional complete denture

Active Comparator

the patients receive conventional complete denture constructed from heat cure acrylic resin

干预措施: conventional complete denture (Other)

CADCAM 3D printed denture

Active Comparator

the patients receiveCADCAM 3D printed denture constructed by using printing machine

干预措施: CADCAM 3D printed denture (Other)

CAD/CAM milled denture

Active Comparator

the patients receiveCADCAM 3D printed denture constructed by using milling machine

干预措施: CAD/CAM milled denture (Other)

结局指标

主要结局

biting force

时间窗: Readings will be performed baseline 1 week after denture insertion then 1 month after denture insertion then 3 months after denture insertion.

- This is done custom-made device composed of Flexiforce A 301® force sensor and Arduino microcontroller with a crystal display. The sensor is calibrated by known weight object for several times, and the sensor is covered by 3 mm layer of putty rubber base material. • The device was placed between the upper and lower first molar. The patient then was instructed to bite as hard as possible for a period of 3 s three times in succession, with at least 20 s of resting between each bite. The readings were recorded, and the average bite force was calculated

次要结局

  • chewing efficiency(3 months after denture insertion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nourhan Ahmed Ragheb

lecturer of prosthodontics

Kafrelsheikh University

研究点 (1)

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