Shamir (Asaf Harofe) Medical Center
Be’er Ya‘aqov, 70300, Israel
Location status: Recruiting
Location contact
Sara Bar Yehuda, PhD
CONTACT
Zoya Haitov Ben Zikri, MD
CONTACT
NCT Number: NCT06473922
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Be’er Ya‘aqov, 70300, Israel
Location status: Recruiting
Sara Bar Yehuda, PhD
CONTACT
Zoya Haitov Ben Zikri, MD
CONTACT
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.
Only the study team can determine whether someone qualifies for participation.
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
General anesthesia
Time frame: From visit 1 which will be 5-7 days before surgery to visit 5 which will be 6 weeks after surgery
Level of fear from pain and dental fear will be monitored by questionnaireד
Time frame: From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery
Will be monitored by the IPR questionnaire
Contact information is provided by the study sponsor or research team.
Sara Bar Yehuda, PhD
CONTACT
Zoya Haitov Ben Zikri, MD
CONTACT
Assaf-Harofeh Medical Center
Other Gov
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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