Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380608
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-09-07
Brief Title:
Levels of Fear Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia
Sponsor:
Zoya Haitov Ben Zikri
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 Surgery or Jaw Implant Surgery Under Local Anesthesia Versus General Anesthesia
Status:
RECRUITING
Status Verified Date:
2024-04
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 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 anxietyIn 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 anxietyfear 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
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 anxietyfear 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
Detailed Description:
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 -
Level of free cortisol in saliva Saliva collection will be performed between 9 am and 12 noon 2 ml of saliva will be collected from the patient by asking the patient to spit into a disposable container
The level of fear of pain - will be measured using the Fear of Pain Questionnaire- FPQ-III which is widely used to assess the fear of pain This questionnaire contains 30 items
The level of fear of dental pain - in this study the short version of the fear of dental pain questionnaire - FDPQ will be used to assess the fear of pain related to a variety of dental procedures
Level of dental anxiety - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah consisting of four questions about different dental conditions
To monitor the inflammation 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
Patients will sign an informed consent form
The patients will answer a questionnaire regarding their demographic characteristics age sex marital status income education medical and dental history
The patients will fill out a fear of pain questionnaire a fear of toothache questionnaire and a fear of dental care questionnaire
The dentist will answer a questionnaire about the dental and medical history of the patients the condition of the teeth the type of anesthesia and the type of treatment that will be performed under anesthesia
A saliva sample will be collected from the patients between 900 and 1200 for cortisol level measurements
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-
The patients will fill out a fear of pain questionnaire a fear of dental pain questionnaire and a dental anxiety anxiety questionnaire
A saliva sample will be collected from the patients between 900 and 1200 for cortisol level measurements
Visit 3 5 days after the operation - in the waiting room of the dental clinic
The patients will fill out a fear of pain questionnaire a fear of toothache questionnaire and a fear of dental care questionnaire
The dentist about the complications and claims reported by the patient
A saliva sample will be collected from the patients between 900 and 1200 for cortisol level measurements
The surgeon will 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
Patients will sign an informed consent form before entering the study The various measurements of the study will include -
Level of free cortisol in saliva Saliva collection will be performed between 9 am and 12 noon 2 ml of saliva will be collected from the patient by asking the patient to spit into a disposable container
The level of fear of pain - will be measured using the Fear of Pain Questionnaire- FPQ-III which is widely used to assess the fear of pain This questionnaire contains 30 items
The level of fear of dental pain - in this study the short version of the fear of dental pain questionnaire - FDPQ will be used to assess the fear of pain related to a variety of dental procedures
Level of dental anxiety - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah consisting of four questions about different dental conditions
To monitor the inflammation 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
Patients will sign an informed consent form
The patients will answer a questionnaire regarding their demographic characteristics age sex marital status income education medical and dental history
The patients will fill out a fear of pain questionnaire a fear of toothache questionnaire and a fear of dental care questionnaire
The dentist will answer a questionnaire about the dental and medical history of the patients the condition of the teeth the type of anesthesia and the type of treatment that will be performed under anesthesia
A saliva sample will be collected from the patients between 900 and 1200 for cortisol level measurements
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-
The patients will fill out a fear of pain questionnaire a fear of dental pain questionnaire and a dental anxiety anxiety questionnaire
A saliva sample will be collected from the patients between 900 and 1200 for cortisol level measurements
Visit 3 5 days after the operation - in the waiting room of the dental clinic
The patients will fill out a fear of pain questionnaire a fear of toothache questionnaire and a fear of dental care questionnaire
The dentist about the complications and claims reported by the patient
A saliva sample will be collected from the patients between 900 and 1200 for cortisol level measurements
The surgeon will 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