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临床试验/NCT04870658
NCT04870658已完成不适用

Patient's Perception of Complications in Implantology. Prospective Multicenter Study.

Aula Dental Avanzada1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2021年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
408
试验地点
1
主要终点
Patient´s pain perception

研究概览

简要总结

To assess the influence that the complications of implant treatment have on the patient's perception and satisfaction on treatment.

详细描述

The study is carried out in 5 dental centers with similar socio-professional characteristics.

The perception of patients with complications in implantology will be evaluated using a questionnaire.

All patients who present some type of complication in a dental treatment with implants will be included. Patients will be included both if they are aware of the complication, that is, they come to the consultation for it, and patients who are diagnosed with a complication in a routine check-up.

Patients will be informed of the complication and before explaining the treatment possibilities, their inclusion in the study will be formalized by signing the Informed Consent document.

Subsequently, they must fill out a questionnaire consisting of 5 questions about their perception of the complication and its influence on their quality of life.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients form 18 to 95 years old. Patients with dental implants supporting one o more implant prosthesis. Patients presenting one treatment complication affecting either dental implant or implant prothesis.

排除标准

  • Patients who does not accept informed consent and do not want to fill the questionnaire.
  • Patients with cognitive impairment. Patients under psychiatric treatment.

结局指标

主要结局

Patient´s pain perception

时间窗: Day 0

The degree of pain perceived by the patient after the onset of the complication by Numeric Rating Scale (NRS) form 0 to 10, being 0 "No pain" and 10 "Very painful".

Degree of Confidence

时间窗: Day 0

The impact that the complication has had on the patient's confidence in dental implant treatment using a numerical rating scale (NRS) from 0 to 10, with 0 being "Confident that they will not receive any further dental implant treatment" and 10 being "Confident that they will".

Degree of Concern

时间窗: Day 0

The degree of concern that the complication generates in the patient by Numeric Rating Scale (NRS) form 0 to 10, being 0 "Not concerned" and 10 "Very concerned".

Functional impairment

时间窗: Day 0

The impact of complication on functional impairment by Numeric Rating Scale (NRS) form 0 to 10, being 0 "Not affected" and 10 "Very affected".

Quality of life (QoL)

时间窗: Day 0

Patient perception of the impact of the complication on their quality of life by Numeric Rating Scale (NRS) form 0 to 10, being 0 "Not affected" and 10 "Very affected".

次要结局

未报告次要终点

研究者

发起方
Aula Dental Avanzada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillem Esteve-Pardo

Principal Investigator

Aula Dental Avanzada

研究点 (1)

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