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
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reginal anesthesia.
- Who it may be relevant to
- Registry conditions: Tooth Extraction. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Levels of Fear and Anxiety and Monitoring Wound Healing Among Patients Who Are About to Undergo Wisdom Tooth Extraction or Jaw Implant Surgery Under Local Anesthesia Versus General Anesthesia
Overview
Tooth extraction is one of the most common surgical procedures in dentistry. Up to 15% of the world's adult population suffers from high anxiety about dental treatments. The stress resulting from this anxiety may cause a delay in the healing and fusion of the surgical wound. Therefore, it is possible to perform this surgical tooth extraction procedure under general anesthesia. The purpose of the present study is to assess the level of anxiety/fear and to 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.
Detailed description
Tooth extraction is one of the most common surgical procedures in dentistry. Up to 15% of the world's adult population suffers from high anxiety about dental treatments. The stress resulting from this anxiety may cause a delay in the healing and fusion of the surgical wound. Therefore, it is possible to perform this surgical tooth extraction procedure under general anesthesia.
The purpose of the present study is to assess the level of anxiety/fear and to 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 various measurements of the study will include:
Level of free cortisol hormone in saliva.The levels of this hormone are correlated to the level of fear
The level of fear of pain will be measured using the Fear of Pain Questionnaire - (FPQ-III)
The level of fear of dental pain will be measured using the short version of the fear of dental pain questionnaire - FDPQ
Level of dental anxiety - will be measured using by the dental anxiety scale of The DAS Corah
. To monitor the inflammation and wound healing, 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. The patients will sign an informed consent form, fill out questionnaires and a saliva test will be taken from them. A clinical assessment will be conducted by the surgeon
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). The patients will fill out questionnaires and a saliva sample will be taken from them
Visit 3: 5 days after the surgery - in the waiting room of the dental clinic The patients will fill out questionnaires and a saliva sample will be taken from them. The surgeon will report complications and complete the IPR.
Visit 4: 14 days after surgery The surgeon will complete the IPR.
Visit 5: 6 weeks after surgery The surgeon will complete the IPR.
Interventions
- Procedure Reginal anesthesia
General anesthesia
Primary outcome measures
- Level of fear [Time frame: From visit 1 which will be 5-7 days before surgery to visit 5 which will be 6 weeks after surgery]
- Wound healing [Time frame: From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Shamir (Asaf Harofe) Medical Center — Be’er Ya‘aqov
Identifiers
NCT: NCT06473922 · g3b8m47a