Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia

NCT ID: NCT06380608

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-12-31

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 anxiety.In 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 anxiety/fear 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 9:00 and 12:00 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 9:00 and 12:00 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 9:00 and 12:00 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.

Conditions

Wisdom Teeth Extraction or Jaw Implant

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Local Anesthesia

Patients who will undergo a dental surgery under local anesthesia

Local anesthesia

Intervention Type: PROCEDURE

Patients who will undergo a dental surgery under local anesthesia

General anesthesia

Patients who will undergo a dental surgery under general anesthesia

General anesthesia

Intervention Type: PROCEDURE

Patients who will undergo a dental surgery under general anesthesia

Interventions

Local anesthesia

Patients who will undergo a dental surgery under local anesthesia

Intervention Type: PROCEDURE

General anesthesia

Patients who will undergo a dental surgery under general anesthesia

Intervention Type: PROCEDURE

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

• Not relevant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zoya Haitov Ben Zikri

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zoya Haitov Ben Zikri

Director of the anesthesia department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zoia Haitov Ben Zikri, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

Shamir (Asaf Harofe) Medical center

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sara Bar Yehuda, PhD

Role: CONTACT

sarabar1@shamir.co.il

972528981004

Facility Contacts

sara Bar Yehuda, MD

Role: primary

sarabar1@shamir.gov.il

972528981004

Other Identifiers

0047-23-ASF

Identifier Type: -

Identifier Source: org_study_id