Tooth ExtractionNCT06473922
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
An observational study of Tooth Extraction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Reginal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2024to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir (Asaf Harofe) Medical Center
Be’er Ya‘aqov, 70300
Sara Bar Yehuda, PhD, 972528981004, sarabar1@shamur.gov.il
Zoya Haitov Ben Zikri, MD, 972537346186, ZoyaC@shamir.gov.il
About this study
Official 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
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.
Read the 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.
- Conditions
- Tooth Extraction
- Being tested
- Reginal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reginal anesthesiaProcedure or surgery
General anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Reginal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of fear
Level of fear from pain and dental fear will be monitored by questionnaireד
Measured: 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
Measured: From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center
- Investigators
- Sara Bar Yehuda, PhD, Study director, Shamir (Asaf Harofe) medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473922
- Sponsor's protocol ID
- g3b8m47a
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06473922
- Acronym / sponsor ID
- g3b8m47a
- Conditions
- Tooth Extraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anasthesia | – | Procedure: Reginal anesthesiaPatients 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. |
| Regional anesthesia | – | Procedure: Reginal anesthesiaPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reginal anesthesiaGeneral anesthesia | Procedure or surgery | General anasthesia, Regional anesthesia |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Bar Yehuda, PhD study director
Shamir (Asaf Harofe) medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Extraction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Bar Yehuda, PhD (972528981004, sarabar1@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.