Clinical trial NCT06473922: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tooth Extraction
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-06-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and females, over 18 years of age who about to undergo surgery to extract 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.

Brief summary: 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.

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:

Primary outcomes:
measure: Level of fear
timeFrame: From visit 1 which will be 5-7 days before surgery to visit 5 which will be 6 weeks after surgery
measure: Wound healing
timeFrame: From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir (Asaf Harofe) Medical Center
Study officials:
affiliation: Shamir (Asaf Harofe) medical center
name: Sara Bar Yehuda, PhD
role: STUDY_DIRECTOR
References: