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临床试验/NCT06324292
NCT06324292尚未招募不适用

Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers: Randomized Clinical Trial

Ain Shams University4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
4
主要终点
quality of life assessment

研究概览

简要总结

The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.

It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture.

详细描述

Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patient's satisfaction. So, the objective of the current study is to find the effect of digital smile design (DSD) on quality of life in complete denture wearers compared to the conventionally created one. The current study is planned to be a crossover randomized Controlled Trial (RCT). The principal investigator, participants and the statistician will be blinded. Simple randomization of the patients in the will take place using a computer generated list (Software informer, Informer Technologies Inc) and allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). Parallel allocation in ratio 1:1 will take place. The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. Afterwards, the authors will be informed by the randomization to be tabulated.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • completely edentulous patients
  • well formed edentulous ridge
  • healthy, pink, non edematous mucosa of even thickness

排除标准

  • heavy smokers
  • patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders
  • patients with physicological or psychiatric condition

研究组 & 干预措施

conventional denture followed by a digital one

Active Comparator

the participants will receive a conventional complete denture followed by a digital one having digital smile design

干预措施: complete denture, CG (Procedure)

Digital denture followed by a conventional one

Active Comparator

the participants will receive a digital complete denture having digital smile design followed by a conventional one

干预措施: complete denture, DG (Procedure)

结局指标

主要结局

quality of life assessment

时间窗: 3 months

OHIP-19 questionnaires for the edentulous patient will be used. A likert scale from 0 to 5 will be employed which zero will denote the ' very bad" experience with the denture and 5 will denote the "excellent" experience

次要结局

未报告次要终点

研究者

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

Ahmed Mostafa Abdelfatah

associate professor of oral and maxillofacial prosthodontics

Ain Shams University

研究点 (4)

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