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

NCT06380608 | Recruiting

• 1 other identifier: 0047-23-ASF
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Wisdom Teeth Extraction or Jaw Implant

Outcome Measures

Primary Outcomes (2)

• Fear and anxiety

  The level of fear of pain will be measured using the Fear of Pain Questionnaire This questionnaire contains 30 items. Each question presents a pain-related situation, and participants are asked to rate FOP on a 5-point Likert scale (not afraid at all, 5= extremely afraid) The level of fear of dental pain will be measured by the short version of the fear of dental pain questionnaire - FDPQ. The questionnaire consists of 18 items and assesses fear of pain associated with a variety of dental procedures. Each item is answered on a rating of 1 (no fear) to 5 (extreme fear), resulting in a possible total score of 18-90. Dental anxiety level - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah. The questionnaire consists of 4 items describing successively situations related to dental treatment: For each item, the subject has to respond using a five point scale.

  7-8 weeks

• Wound heeling

  The Inflammatory Proliferative Remodeling (IPR) Wound Healing Scale will be used in order to evaluate the wound healing. The scale is divided into three subscales corresponding to the three phases of wound healing: The inflammatory phase (days 3-5 postoperatively), The proliferative phase (14 days postoperatively) and the remodeling phase (6 weeks postoperatively). Each clinical manifestation was scored 0 or 1, yielding three subscale scores ranging from 0-8, 0-5, and 0-3, accordingly.

  7-8 weeks

Study Arms (2)

Local Anesthesia

Patients who will undergo a dental surgery under local anesthesia

Procedure: Local anesthesia

General anesthesia

Patients who will undergo a dental surgery under general anesthesia

Procedure: General anesthesia

Interventions

Local anesthesia PROCEDURE

Patients who will undergo a dental surgery under local anesthesia

Local Anesthesia

General anesthesia PROCEDURE

Patients who will undergo a dental surgery under general anesthesia

General anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are about to undergo a dental surgery under local or general anesthesia

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.

You may not qualify if:

• Not relevant

Sponsors & Collaborators

• Zoya Haitov Ben Zikri: lead

Study Sites (1)

Shamir (Asaf Harofe) Medical center

Be’er Ya‘aqov, 60930, Israel

RECRUITING

MeSH Terms

Interventions

Anesthesia, Local; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Zoia Haitov Ben Zikri, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Bar Yehuda, PhD

CONTACT

972528981004; sarabar1@shamir.co.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the anesthesia department

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: April 24, 2024
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)