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临床试验/NCT06164366
NCT06164366尚未招募不适用

Patient Satisfaction and Adaptation of Maxillary Resin Dentures Printed at 0 Versus 45 Degrees Build Angle: A Randomized Pilot Cross-over Clinical Trial

Cairo University0 个研究点目标入组 10 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
主要终点
patient satisfaction

研究概览

简要总结

This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.

详细描述

This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above the age of 40
  • Patients with opposing full natural dentition or completely or partially edentulous arches
  • Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants
  • Cooperative patients that are willing to attend all follow-up periods.
  • Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
  • 6- Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes

排除标准

  • Patients with any temporomandibular joint disorder or parafunctional habits
  • Patients with flabby or flat ridges
  • Patients with extreme anatomical limitations such as a large torus that requires surgical excision.
  • Patients with a history of allergy to dentures made of resins.
  • Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
  • Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

结局指标

主要结局

patient satisfaction

时间窗: 6 months

Measured through a questionnaire using a likert scale from 1 - 5 with 1 being extremely satisfied with the intervention and 5 being extremely satisfied with the intervention

denture adaptation

时间窗: 4 weeks

measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation

次要结局

  • Denture retention(6 months)

研究者

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

Iman Abd-ElWahab Radi, PhD

Professor

Cairo University

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