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临床试验/NCT03043456
NCT03043456Unknown不适用

Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures

Cairo University0 个研究点目标入组 24 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Changes in Patient satisfaction

研究概览

简要总结

In this research, the investigators are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their satisfaction and microbiological count.

详细描述

The restoration of masticatory function and aesthetics is an important aim in dentistry mainly when patients present with extensive tooth loss. The loss of tooth in elderly patients not only impairs the stomatognathic system but also their psychological status and quality of life.so an important criteria's for the success of dentures are patient's expectations and the ability of the denture to replace the lost masticatory efficiency.

The acrylic resin was first used in 1936; it was in that time the best alternative for vulcanized rubber. Where it is characterized by superior characteristics and became the most popular material used since then. Nonetheless, it has some problems such as polymerization shrinkage, weak flexural, lower impact strength, and low fatigue resistance. These often lead to denture failure during chewing or when fall out of the patient's hand. In order to enhance some properties of PMMA, various efforts have been taken including addition of metal wires or plates, fibers, metal inserts, and modification of chemical structure. In recent years, nylon polymer has attracted attention as a denture base material.

Thermoplastic nylon like materials or polyamides were introduced and first used in dentistry in 1950. The polyamide are uniquely characterized by high esthetics especially in removable partial dentures, where retentive components are recommended anteriorly by this material which provide high elasticity we can make the retentive components using the same material and eliminate the metallic clasps.

Polyamides are characterized by low weight and flexibility make it more patient satisfactory and fortunately it has no monomer remnants that may affect patient health and causes allergy. Thermoplastic polyamides have almost no porosity which eliminates water sorption. The technique used for its fabrication is injection molding technique which is more dimension accurate than packing mold technique.

Valplast was initially used just over 50 years ago and has been used in modern dentistry since the mid-fifties. A variation of nylon, which is far more flexible and stronger than poly methyl methacrylate resin, is used in many alternative partial dentures. Valplast flexible dentures are used for full sets of dentures especially in cases of acrylic allergy which represent 20% of the population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The study will be blinded regarding the statistician who is responsible for data analysis.

The participant patients will be blinded. The outcome assessor for patient satisfaction can be blinded during the questionnaire. On the other hand, Microbial count assessor will not be blinded during swab taking while the lab technician can be blinded. but The operator cannot be blinded.

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Completely edentulous
  • •No bone irregularities, no bone specules, mild to moderate undercut.
  • •Good oral hygiene
  • •Should be co-operative
  • •No serious systemic disease
  • •No TMJ Problems

排除标准

  • •Bone irregularities , soft tissue ulcerations , severe undercuts
  • •Serious systemic problem
  • •Patient with xerostomia
  • •Severely resorbed ridge
  • •Logistic or physical reasons that could affect follow-up,
  • •Psychiatric problems
  • •Medically compromised patients & those with neuromascular disorders

研究组 & 干预措施

Thermoplastic Resin group

Active Comparator

Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)

干预措施: Thermoplastic complete denture (Device)

conventional acrylic resin group

Placebo Comparator

Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)

干预措施: Conventional acrylic resin complete denture (Device)

结局指标

主要结局

Changes in Patient satisfaction

时间窗: 0 months , 3 months , 6 months

Questionnaire

次要结局

  • changes in Microbial count(0 months , 3 months , 6 months)

研究者

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

Mohamed Ahmed Abdel Hamid

Dr.

Cairo University

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