Assessing Levels of Fear and Anxiety and Monitoring Wound Healing Among Patients Who Are About to Undergo Wisdom Tooth Extraction Surgery or Jaw Implant Surgery Under Local Anesthesia Versus General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Fear and anxiety
研究概览
简要总结
Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia.
A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly.
The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia.
详细描述
The study will include subjects who are about to undergo extraction of wisdom teeth or no more than 3 implants in the jaw under local anesthesia in the dental clinic or under general anesthesia in a hospital operating room.
Patients will sign an informed consent form before entering the study. The various measurements of the study will include -
- Level of free cortisol in saliva. Saliva collection will be performed between 9 am and 12 noon. 2 ml of saliva will be collected from the patient by asking the patient to spit into a disposable container.
- The level of fear of pain - will be measured using the Fear of Pain Questionnaire- (FPQ-III), which is widely used to assess the fear of pain. This questionnaire contains 30 items.
- The level of fear of dental pain - in this study the short version of the fear of dental pain questionnaire - FDPQ will be used to assess the fear of pain related to a variety of dental procedures.
- Level of dental anxiety - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah consisting of four questions about different dental conditions
- To monitor the inflammation, the inflammatory proliferation scale (IPR) will be used to monitor the wound healing process.
The study includes 5 visits:
Visit 1: 5-7 days before surgery - in the waiting room of the dental clinic
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - from ≥ 18 years,
- •ASA 1- or 2,
- •Signing a written informed consent before starting all procedures related to the research,
- •Ability to cooperate with the researcher and meet the research requirements.
排除标准
- •Not relevant
结局指标
主要结局
Fear and anxiety
时间窗: 7-8 weeks
The level of fear of pain will be measured using the Fear of Pain Questionnaire This questionnaire contains 30 items. Each question presents a pain-related situation, and participants are asked to rate FOP on a 5-point Likert scale (not afraid at all, 5= extremely afraid) The level of fear of dental pain will be measured by the short version of the fear of dental pain questionnaire - FDPQ. The questionnaire consists of 18 items and assesses fear of pain associated with a variety of dental procedures. Each item is answered on a rating of 1 (no fear) to 5 (extreme fear), resulting in a possible total score of 18-90. Dental anxiety level - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah. The questionnaire consists of 4 items describing successively situations related to dental treatment: For each item, the subject has to respond using a five point scale.
Wound heeling
时间窗: 7-8 weeks
The Inflammatory Proliferative Remodeling (IPR) Wound Healing Scale will be used in order to evaluate the wound healing. The scale is divided into three subscales corresponding to the three phases of wound healing: The inflammatory phase (days 3-5 postoperatively), The proliferative phase (14 days postoperatively) and the remodeling phase (6 weeks postoperatively). Each clinical manifestation was scored 0 or 1, yielding three subscale scores ranging from 0-8, 0-5, and 0-3, accordingly.
次要结局
未报告次要终点
研究者
Zoya Haitov Ben Zikri
Director of the anesthesia department
Assaf-Harofeh Medical Center