Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473922
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
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
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tooth extraction is one of the most common surgical procedures in dentistry Up to 15 of the worlds 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 anxietyfear 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 purpose of the present study is to assess the level of anxietyfear 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 worlds 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 anxietyfear 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 salivaThe 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
The purpose of the present study is to assess the level of anxietyfear 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 salivaThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None