Wisdom Teeth Extraction or Jaw ImplantNCT06380608
Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia
An observational study of Wisdom Teeth Extraction or Jaw Implant, run by Zoya Haitov Ben Zikri at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wisdom Teeth Extraction or Jaw Implant
- What is being tested?
- Local anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2023to 31 Dec 2024
- How long will I take part?
- 7 Weeks
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are about to undergo a dental surgery under local or general anesthesia
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
- Not relevant
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir (Asaf Harofe) Medical center
Be’er Ya‘aqov, 60930
sara Bar Yehuda, MD, 972528981004, sarabar1@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 Surgery or Jaw Implant Surgery Under Local Anesthesia Versus General Anesthesia
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.
Read the detailed description
The study will include subjects who are about to undergo extraction of 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.
Patients will sign an informed consent form before entering the study. The various measurements of the study will include -
- Level of free cortisol in saliva. Saliva collection will be performed between 9 am and 12 noon. 2 ml of saliva will be collected from the patient by asking the patient to spit into a disposable container.
- The level of fear of pain - will be measured using the Fear of Pain Questionnaire- (FPQ-III), which is widely used to assess the fear of pain. This questionnaire contains 30 items.
- The level of fear of dental pain - in this study the short version of the fear of dental pain questionnaire - FDPQ will be used to assess the fear of pain related to a variety of dental procedures.
- Level of dental anxiety - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah consisting of four questions about different dental conditions
- To monitor the inflammation, 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
- Patients will sign an informed consent form.
- The patients will answer a questionnaire regarding their demographic characteristics (age, sex, marital status, income, education, medical and dental history).
- The patients will fill out a fear of pain questionnaire, a fear of toothache questionnaire and a fear of dental care questionnaire
- The dentist will answer a questionnaire about the dental and medical history of the patients, the condition of the teeth, the type of anesthesia and the type of treatment that will be performed under anesthesia.
- A saliva sample will be collected from the patients between 9:00 and 12:00 for cortisol level measurements.
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) before the procedure-
- The patients will fill out a fear of pain questionnaire, a fear of dental pain questionnaire and a dental anxiety anxiety questionnaire.
- A saliva sample will be collected from the patients between 9:00 and 12:00 for cortisol level measurements.
Visit 3: 5 days after the operation - in the waiting room of the dental clinic
- The patients will fill out a fear of pain questionnaire, a fear of toothache questionnaire and a fear of dental care questionnaire.
- The dentist about the complications and claims reported by the patient
- A saliva sample will be collected from the patients between 9:00 and 12:00 for cortisol level measurements.
- The surgeon will 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
- Wisdom Teeth Extraction or Jaw Implant
- Being tested
- Local anesthesia, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesiaProcedure or surgery
Patients who will undergo a dental surgery under local anesthesia
General anesthesiaProcedure or surgery
Patients who will undergo a dental surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthesia | Patients who will undergo a dental surgery under local anesthesia Receives: Procedure: Local anesthesia | |
| General anesthesia | Patients who will undergo a dental surgery under general anesthesia Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wisdom Teeth Extraction or Jaw ImplantStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
- Target duration
- 7 Weeks
Sponsor and investigators
- Lead sponsor
- Zoya Haitov Ben Zikri
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center
- Investigators
- Zoia Haitov Ben Zikri, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380608
- Sponsor's protocol ID
- 0047-23-ASF
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2023
- Last updated
- 24 Apr 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 24 Apr 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 Surgery or Jaw Implant Surgery Under Local Anesthesia Versus General Anesthesia
- ClinicalTrials.gov ID
- NCT06380608
- Acronym / sponsor ID
- 0047-23-ASF
- Conditions
- Wisdom Teeth Extraction or Jaw Implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Zoya Haitov Ben ZikriOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Apr 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 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.
Detailed description
The study will include subjects who are about to undergo extraction of 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.
Patients will sign an informed consent form before entering the study. The various measurements of the study will include -
- Level of free cortisol in saliva. Saliva collection will be performed between 9 am and 12 noon. 2 ml of saliva will be collected from the patient by asking the patient to spit into a disposable container.
- The level of fear of pain - will be measured using the Fear of Pain Questionnaire- (FPQ-III), which is widely used to assess the fear of pain. This questionnaire contains 30 items.
- The level of fear of dental pain - in this study the short version of the fear of dental pain questionnaire - FDPQ will be used to assess the fear of pain related to a variety of dental procedures.
- Level of dental anxiety - dental anxiety will be assessed by the dental anxiety scale of The DAS Corah consisting of four questions about different dental conditions
- To monitor the inflammation, 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
- Patients will sign an informed consent form.
- The patients will answer a questionnaire regarding their demographic characteristics (age, sex, marital status, income, education, medical and dental history).
- The patients will fill out a fear of pain questionnaire, a fear of toothache questionnaire and a fear of dental care questionnaire
- The dentist will answer a questionnaire about the dental and medical history of the patients, the condition of the teeth, the type of anesthesia and the type of treatment that will be performed under anesthesia.
- A saliva sample will be collected from the patients between 9:00 and 12:00 for cortisol level measurements.
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) before the procedure-
- The patients will fill out a fear of pain questionnaire, a fear of dental pain questionnaire and a dental anxiety anxiety questionnaire.
- A saliva sample will be collected from the patients between 9:00 and 12:00 for cortisol level measurements.
Visit 3: 5 days after the operation - in the waiting room of the dental clinic
- The patients will fill out a fear of pain questionnaire, a fear of toothache questionnaire and a fear of dental care questionnaire.
- The dentist about the complications and claims reported by the patient
- A saliva sample will be collected from the patients between 9:00 and 12:00 for cortisol level measurements.
- The surgeon will 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
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthesia | – | Procedure: Local anesthesiaPatients who will undergo a dental surgery under local anesthesia |
| General anesthesia | – | Procedure: General anesthesiaPatients who will undergo a dental surgery under general anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are about to undergo a dental surgery under local or general anesthesia
Key inclusion criteria (4 listed)
- Age - from ≥ 18 years,
Key exclusion criteria (1 listed)
- Not relevant
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 |
|---|---|---|
| Local anesthesiaPatients who will undergo a dental surgery under local anesthesia | Procedure or surgery | Local Anesthesia |
| General anesthesiaPatients who will undergo a dental surgery under general anesthesia | Procedure or surgery | General anesthesia |
Primary outcome
Fear and anxiety
Time frame: 7-8 weeks
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.
Wound heeling
Time frame: 7-8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 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.
Zoia Haitov Ben Zikri, MD principal investigator
Assaf-Harofeh 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 Wisdom Teeth Extraction or Jaw Implant, run by Zoya Haitov Ben Zikri 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 4 inclusion and 1 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 24 Apr 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.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear and anxiety (time frame: 7-8 weeks). 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 24 Apr 2024.