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

NCT ID: NCT06473922

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-08-30

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.

Conditions

Tooth Extraction

Study Design

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

Study Groups

General anasthesia

Patients who are about to undergo surgery to extract wisdom teeth or no more than 3 implants in the jaw under general anesthesia in a hospital operating room.

Reginal anesthesia

Intervention Type: PROCEDURE

General anesthesia

Regional anesthesia

Patients who are about to undergo surgery to extract wisdom teeth or no more than 3 implants in the jaw under regional anesthesia in the dental clinic

Reginal anesthesia

Intervention Type: PROCEDURE

General anesthesia

Interventions

Reginal anesthesia

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zoya Haitov Ben Zikri

Manager of the anesthesia unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Bar Yehuda, PhD

Role: STUDY_DIRECTOR

Shamir (Asaf Harofe) 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.gov.il

972528981004

Zoya Haitov Ben Zikri, MD

Role: CONTACT

ZoyaC@shamir.gov.il

972537346186

Facility Contacts

Sara Bar Yehuda, PhD

Role: primary

sarabar1@shamur.gov.il

972528981004

Zoya Haitov Ben Zikri, MD

Role: backup

ZoyaC@shamir.gov.il

972537346186

Other Identifiers

g3b8m47a

Identifier Type: -

Identifier Source: org_study_id