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临床试验/NCT04448093
NCT04448093已完成早期 1 期

Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis: A Comparative Study.

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
121
试验地点
2
主要终点
Dental treatment

研究概览

简要总结

The objective of this work will be to conduct a controlled clinical trial to assess whether the dental treatment of adequacy of the oral environment is capable of generating improvement in the quality of life and self-esteem, comparing the results of patients on hemodialysis who received treatment with others who did not receive treatment .

详细描述

After selecting the sample, patients will undergo an oral examination performed by a dental surgeon, in which they will be evaluated for the presence of lesions in the oral mucosa, periodontal conditions through simplified periodontal record - PSR, oral hygiene index, caries and lack of teeth - DMFT, if they need treatment and the situation of the prosthesis, if they use them, the data being recorded in a specific medical record. Subsequently, intervention will be performed in the group that received the treatment (intervention group). The treatment will consist of the adequacy of the oral environment in patients with teeth and evaluation of the mucosa and prostheses for edentulous patients.

The service will take place at the UFVJM Surgery and Periodontics Clinic, on previously scheduled days and times. About 5 to 10 days before treatment, patients answered questionnaires about socioeconomic characterization, self-esteem and quality of life. The therapeutic protocol followed during the service will be the one proposed by Quirynen (1995) [22], in which the debridement of the entire mouth is recommended in a single 45-minute session. After removing the supra and subgingival biofilm, the patient will be instructed to use mouthwashes with 15 ml of 0.12% chlorhexidine gluconate, for one minute, twice a day, thirty minutes after brushing, for seven days. In this phase, emergency extractions, restoration of restorations and cavity closure with glass ionomer cement and resins in the anterior teeth will also be performed, in order to adapt the oral environment in minimal interventions, considering the patient's systemic state.

All patients who have at least 1 tooth, healthy or not, will be considered dentate. Toothless patients will receive guidance on oral hygiene and prostheses, if used, and will also use mouthwash with 0.12% chlorhexidine gluconate for the same period. Group participants who were not submitted to the intervention (control group), received the same initial assessment and answered the same questionnaires, but will not be treated at that time. After 45 days from the end of the dental treatment, everyone will be reassessed, went through oral hygiene instructions again and answered the questionnaires, the questions being directed to the patient's perception in the last 45 days after treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients over 18 years
  • submitted to hemodialysis
  • agreed to participate voluntarily by invitation and sign an informed consent form

排除标准

  • severe anemia
  • uncontrolled systolic and diastolic blood pressure or greater than 180/110 mmHg
  • unstable angina, complex ventricular arrhythmias, severe metabolic disease
  • acute myocardial infarction less than a month
  • acute conditions, aortic aneurysm, severe aortic stenosis or respiratory impairment
  • neurological and / or musculoskeletal that contraindicate treatment

结局指标

主要结局

Dental treatment

时间窗: 6 years

Comparison of quality of life and self-esteem results of patients who underwent dental treatment with others who did not.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Flecha

Principal Investigator

Federal University of São Paulo

研究点 (2)

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