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临床试验/NCT06388265
NCT06388265已完成不适用

Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars

University of Barcelona2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Changes in STAI-S

研究概览

简要总结

Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

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

入选标准

  • Individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars.

排除标准

  • Systemic diseases (ASA III or IV) that contraindicate the performance of the surgical procedure
  • Pregnant women
  • Individuals that did not understand and/or could not respond the given questionnaire.
  • Patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time.
  • Patients who had undergone extraction of a third molar in the twelve months prior to the current visit.
  • Patients taking antidepressant medication or anxiolytic medication

结局指标

主要结局

Changes in STAI-S

时间窗: Through study completion, an average of 5 weeks

The Anxiety State scale (S-Anxiety) is an inventory that has been validated and assesses the current state of anxiety of the participant measured through an auto evaluation, asking how the evaluated individual feels "in this moment", using items that measure subjective feelings of apprehension, tension, nervousness, worry and activation/excitement of the autonomic nervous system. The total scores can go from 20 to 80 points A cut point value of 39 to 40 points has been suggested to detect clinically significant symptoms in the Anxiety State scale. STAI-S will be assessed in 4 stages: 1. At the initial consultation (baseline) 2. Immediately before the procedure and administration of the local anaesthetic solution 3. Immediately after the procedure is completed 4. 1 week after the procedure (exodontia)

Changes in MDAS

时间窗: up to 3 weeks

The modified dental anxiety scale (MDAS) is an auto evaluation questionnaire about dental anxiety that contains 5 items, each one with 5 possible answers that reflects in order an increase of anxiety (no anxiety to extremely anxious). The total score can go from 5 points to a maximum of 25 points. The lower limit to define an individual with extreme anxiety is 19 points and to define the presence of anxiety the score must be higher than 10 points. MDAS will be assessed in 2 stages: 1. At the initial consultation (baseline) 2. Immediately before the procedure and administration of the local anaesthetic solution

次要结局

  • Changes in blood pressure(Through study completion, an average of 5 weeks)
  • Changes in Heart rate(Through study completion, an average of 5 weeks)
  • Changes in Oxygen saturation(Through study completion, an average of 5 weeks)
  • Patient Satisfaction of procedure(1 week after the procedure)
  • Changes in blood pressure(Through study completion, an average of 5 weeks)
  • Changes in Heart rate(Through study completion, an average of 5 weeks)
  • Changes in Oxygen saturation(Through study completion, an average of 5 weeks)
  • Patient Satisfaction of procedure(1 week after the procedure)

研究者

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

Mayra Schemel Suarez

Principal Investigator

University of Barcelona

研究点 (2)

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