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

NCT06473922 | Recruiting

• 1 other identifier: g3b8m47a
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (2)

• Level of fear

  Level of fear from pain and dental fear will be monitored by questionnaireד

  From visit 1 which will be 5-7 days before surgery to visit 5 which will be 6 weeks after surgery

• Wound healing

  Will be monitored by the IPR questionnaire

  From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery

Study Arms (2)

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.

Procedure: Reginal 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

Procedure: Reginal anesthesia

Interventions

Reginal anesthesia PROCEDURE

General anesthesia

General anasthesia; Regional anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and females, over 18 years of age who about to undergo surgery to extract 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, 70300, Israel

RECRUITING

Study Officials

• Sara Bar Yehuda, PhD

  Shamir (Asaf Harofe) medical center

  STUDY DIRECTOR

Central Study Contacts

Sara Bar Yehuda, PhD

CONTACT

972528981004; sarabar1@shamir.gov.il

Zoya Haitov Ben Zikri, MD

CONTACT

972537346186; ZoyaC@shamir.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of the anesthesia unit

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion: May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)