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NCT Number: NCT06473922

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reginal anesthesia

Procedure

General anesthesia

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Bar Yehuda, PhD

CONTACT

[email protected]

972528981004

Zoya Haitov Ben Zikri, MD

CONTACT

[email protected]

972537346186

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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