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

June 19, 2024 updated by: Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel, 70300
        • Recruiting
        • Shamir (Asaf Harofe) Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Procedure: Reginal anesthesia
General anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of fear
Time Frame: From visit 1 which will be 5-7 days before surgery to visit 5 which will be 6 weeks after surgery
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
Time Frame: From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Study Director: Sara Bar Yehuda, PhD, Shamir (Asaf Harofe) Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • g3b8m47a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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