Actively Recruiting

Age: 18Years - 85Years
All Genders
ID06473922

Assessing Levels of Fear and Anxiety and Monitoring Wound Healing Among Patients Undergoing Wisdom Tooth Extraction or Jaw Implant Surgery Under Local Versus General Anesthesia

Led by Assaf-Harofeh Medical Center · Updated on 2024-06-25

46

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Tooth extraction is a common dental surgery, and many adults experience high anxiety about dental treatments, which may slow healing after surgery. This research aims to compare anxiety levels and wound healing in patients undergoing wisdom tooth removal or up to three jaw implants using either local anesthesia in a dental clinic or general anesthesia in a hospital operating room. The study will assess fear and anxiety levels along with monitoring the healing process after surgery. Participants will be grouped based on their planned anesthesia type: local (regional) anesthesia in a dental clinic or general anesthesia in a hospital. The study involves five visits starting 5 to 7 days before surgery, continuing through surgery day, and follow-ups at 5 days, 14 days, and 6 weeks after surgery. During these visits, patients will complete questionnaires and provide saliva samples to measure cortisol levels related to fear. Surgeons will assess wound healing using an inflammatory proliferation scale at follow-up visits. Patients will be asked about their fear and anxiety using several questionnaires, and saliva tests will measure hormone levels linked to stress. Surgeons will track complications and wound healing progress across the follow-up visits. The main outcomes measured are changes in fear levels from before surgery up to six weeks after and wound healing from 5 days to 6 weeks post-surgery. This observational study is sponsored by Assaf-Harofeh Medical Center and includes adults aged 18 to 85 who are able to cooperate and provide consent.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ASA physical status 1 or 2
  • Able to sign informed consent before starting study procedures
  • Able to cooperate with the researcher and meet study requirements
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 5 to 7 days before surgery

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo wisdom tooth extraction or jaw implant surgery under either general or regional anesthesia.

1 visit (in-person)

Post-operative Follow-up

Duration - 6 weeks following surgery

Participants are monitored for wound healing and anxiety levels after surgery.

4 visits (5 days, 14 days, and 6 weeks after surgery)

Trial Site Locations

Total: 1 location

1

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, Israel, 70300

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Research Team

S

Sara Bar Yehuda, PhD

Z

Zoya Haitov Ben Zikri, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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