An observational study in Wisdom Teeth Extraction or Jaw Implant, sponsored by Zoya Haitov Ben Zikri. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Zoya Haitov Ben Zikri · Observational
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.
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 -
The study includes 5 visits:
Visit 1: 5-7 days before surgery - in the waiting room of the dental clinic
Visit 2: On the day of surgery, in the waiting room of the dental clinic or the operating room (depending on the type of anesthesia planned) before the procedure-
Visit 3: 5 days after the operation - in the waiting room of the dental clinic
This is the only study on the registry with Zoya Haitov Ben Zikri as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects who are about to undergo a dental surgery under local or general anesthesia
Age - from ≥ 18 years,
Exclusion Criteria:
Patients who will undergo a dental surgery under local anesthesia
Procedure: Local anesthesia
Patients who will undergo a dental surgery under general anesthesia
Procedure: General anesthesia
Patients who will undergo a dental surgery under local anesthesia
Patients who will undergo a dental surgery under general anesthesia
Fear and anxiety
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.
Time frame: 7-8 weeks
Wound heeling
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.
Time frame: 7-8 weeks
Plan to share: No
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