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临床试验/NCT02322983
NCT02322983已完成不适用

Effect Evaluation of Conscious Sedation With Nitrous Oxide at Control of Stress During Dental Care in Individuals With Cerebral Palsy.

Universidade Cruzeiro do Sul2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
2
主要终点
Venham's Score

研究概览

简要总结

Cerebral Palsy induces oral alterations that impact on oral health, requiring dental treatment. The objective of this study was to evaluate the use of conscious sedation with nitrous oxide (N2O) in the control of stress during dental treatment in individuals with Cerebral Palsy.

详细描述

Were invited and accepted to participate in this study, 77 individuals with Cerebral Palsy who attended the outpatient clinic of San Francisco Home School (SFHS) at the time of data collection.

This study served as a non-randomized experimental trial conducted between 2011/2012 at dental ambulatory in the SFHS. Dental care routines have been established, by standardizing procedures and ensuring the reproducibility of the method of sedation. In the initial consultation, medical history taking (collecting sociodemographic data of the participants) and dental examination was performed. Data relating to the Cerebral Palsy clinical standard were collected from medical records of patients and noted in the evaluation sheet developed specifically for this research. Were provided to guardians the clarifications regarding sedation technique and treatment planning.

At dental examination the diagnostic criteria of caries followed those proposed by the World Health Organization (WHO). On the second visit, the patient was stabilized in the dental chair under mechanical contention. Performed adaptation and selection of nasal mask, monitoring equipment were positioned, starting the observation and recording of the behavioral and physiological records in the evaluation sheets. The proportion of gas was manipulated relative to the percentage between nitrous oxide and oxygen to achieve optimal sedation. In this study, it was considered a good sedation for Cerebral Palsy patient when he showed a certain degree of relaxation, which becomes more cooperative with treatment.

Behavioral assessment in relation to dental treatment was measured by Venham's Score, standard used for behavioral assessment of the dental patient, and the measurement performed according to the patient's behavior during the dental procedure.

Due to the subjectivity which compose the diagnosis of diseases or behavior analysis, it is common to occur some variation in the results. In the specific situation of a study, there is the aggravation of multiple observations be conducted on the same day, so that fatigue could lead to inconsistent diagnoses. For this reason, only one patient per day received dental care with nitrous oxide (N2O). In light of the above considerations, two dentists were calibrated to evaluate behavior in Venham's Score.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Cerebral Palsy medical diagnosis;
  • Age over 3 years old without distinction by gender;
  • Patients with any clinical patterns of Cerebral Palsy;
  • Patients with caries in at least two molars (primary or permanent), indicating anesthetic use for performing the restorative procedure.

排除标准

  • Patients with chronic respiratory problems (such as chronic bronchitis, COPD) or acute (like flu with nasal congestion and active pneumonia) as these conditions contraindicate the use of N2O;
  • Cerebral Palsy patients with genetic syndromes associated;
  • Patients whose caregivers refused to sign the Instrument of Consent and the Consent of the Use of Conscious Sedation.

结局指标

主要结局

Venham's Score

时间窗: data were collected and participants were followed up during dental care. An expected average of 1 hour.

Heart Rate

时间窗: data were collected and participants were followed up during dental care. An expected average of 1 hour.

Nitrous oxide and Oxygen Proportion

时间窗: data were collected and participants were followed up during dental care. An expected average of 1 hour.

Respiratory Rate

时间窗: data were collected and participants were followed up during dental care. An expected average of 1 hour.

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

Fernando Martins Baeder

Researcher and professor of the degree program.

Universidade Cruzeiro do Sul

研究点 (2)

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