Dental AnxietyNCT04207515
The Effect of Conscious Sedation on Acute Stress
A study testing Procedures of wisdom tooth removal surgery under conscious sedation and Procedures of wisdom tooth removal surgery under local anesthesia in people with Dental Anxiety and Dental Fear, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
The specific aims of the present study were to evaluate sAA responses to impacted third molar extractions at different time points in the patients under conscious sedation with local anesthesia and to examine the relationship between sAA, conscious sedation and dental anxiety. Read more about this study
- Who is it for?
- Ages 19 to 33 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Fear, Tooth Extraction Status Nos
- What is being tested?
- Procedures of wisdom tooth removal surgery under conscious sedation and Procedures of wisdom tooth removal surgery under local anesthesia
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 20 Sep 2019
- Phase
- Interventional
- 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 19 to 33 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man
- 18-35 years
- individuals without chemotherapy or radiotherapy history
- individuals without antibiotics and NSAIDs history in the last month
- individuals without any medications that affect saliva content in the last 1 month
- individuals without corticosteroid treatment history
Show all 11Show fewer
- nonsmokers
- wisdom tooth which is indicated to extract
- individuals without acute infectious lesion in the mouth
- individuals without alcohol or substance abuse
- individuals without inflammatory bone disease
Who cannot join
- Woman
- individuals with any systemic disorders
- individuals with chemotherapy and radiotherapy history
- individuals with antibiotics and NSAIDs history in the last month
- individuals with use of antibiotics and NSAIDs history in the last month
- individuals with corticosteroid treatment history
Show all 10Show fewer
- Smokers
- individuals with acute infectious lesion in the mouth
- individuals with inflammatory bone disease
- individuals with alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Conscious Sedation on Salivary Alpha-Amylase Levels in the Patients Undergoing Impacted Third Molar Surgery
The specific aims of the present study were to evaluate sAA responses to impacted third molar extractions at different time points in the patients under conscious sedation with local anesthesia and to examine the relationship between sAA, conscious sedation and dental anxiety. The null hypothesis was that conscious sedation could be considered to reduce salivary alpha amylase level during the wisdom tooth surgery.
Read the detailed description
In oral and maxillofacial surgery, surgical extraction of impacted third molars is one of the most common surgical techniques performed in the oral cavity. Conscious intravenous sedation could be administered for the patients to provide anxiolysis, sedation, and analgesia for the patient. Salivary alpha-amylase (sAA) which reflect stress-related changes in the autonomic nervous system (ANS), has been proposed as a non-invasive stress biomarker. The aim of the present study was to investigate whether salivary alpha amylase (sAA) levels could be decreased by conscious sedation in the patients undergoing impacted third molar extraction. A total of 18 male patients were recruited. All patients were administered Modified Dental Anxiety Scale (MDAS) test. Patients were divided into two groups: test group (procedures under sedation) and control group (procedures under local anesthesia). The following parameters were monitored at different study time-points: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SO2), and heart rate (HR). Five samples of saliva were taken from each patient: the first time patient came to clinic, the patient sat in the chair for extraction, before local anesthesia, immediately after extraction, at 4 h after extraction. The concentrations of sAA were measured and compared across the different stages of the study between two groups.
- Conditions
- Dental Anxiety, Dental Fear, Tooth Extraction Status Nos
- Being tested
- Procedures of wisdom tooth removal surgery under conscious sedation, Procedures of wisdom tooth removal surgery under local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedures of wisdom tooth removal surgery under conscious sedationProcedure or surgery
The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
Procedures of wisdom tooth removal surgery under local anesthesiaProcedure or surgery
The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Removal of wisdom tooth under conscious sedation | Experimental | patients were asked to fill MDAS form which consists of five questions. Systolic blood pressure, diastolic blood pressure, oxygen saturation , and heart rate were monitored at different time points: preoperative time ; intraoperative time-after local anesthesia , intraoperative time-after extraction , postoperative time . In this group removal of wisdom teeth was done under conscious sedation. During surgery procedures five saliva samples were collected. Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
Ibuprofen (600 mg every 8 h for 7 days) and amoxicillin/clavulanate (875 mg/125 mg every 8 h for 5 days) were prescribed. Detailed explanation of oral hygiene techniques and recommendations for the postoperative period were given to each patient. Receives: Procedure: Procedures of wisdom tooth removal surgery under conscious sedation |
| Removal of wisdom tooth under local anesthesia | Active comparator | patients were asked to fill MDAS form which consists of five questions. Systolic blood pressure, diastolic blood pressure , oxygen saturation , and heart rate were monitored at different time points: preoperative time ; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time. In this group, removal of wisdom teeth was done under local anesthesia. During surgery procedures five saliva samples were collected. Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
Ibuprofen (600 mg every 8 h for 7 days) and amoxicillin/clavulanate (875 mg/125 mg every 8 h for 5 days) were prescribed. Detailed explanation of oral hygiene techniques and recommendations for the postoperative period were given to each patient. Receives: Procedure: Procedures of wisdom tooth removal surgery under local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Alpha Amylase Level
The measurement of salivary alpha amylase levels (t1. The first time the patient came to clinic, t2. When the patient sat in the chair for extraction, t3. Before local anesthesia, t4. Immediately after extraction, t5. 4 h after extraction)
Measured: Change from baseline salivary alpha-amylase levels at different time points in one day
Secondary outcomes (4)
Systolic blood pressure (SBP) level
The measurement of Systolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)
Measured: Change from baseline systolic blood pressure levels at different time points in one day
Diastolic blood pressure (DBP) level,
Diastolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)
Measured: Change from baseline diastolic blood pressure levels at different time points in one day
Oxygen saturation (SO2) level
Oxygen saturation (SO2) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)
Measured: Change from baseline oxygen saturation levels at different time points in one day
Heart rate (HR) level
Heart rate (HT) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)
Measured: Change from baseline heart rate levels at different time points in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Apr 2018
- Primary completion15 Jun 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdullah Tolga Şitilci, Principal investigator, Istanbul University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207515
- Sponsor's protocol ID
- 2018/24
- Status last verified
- Apr 2018
- First submitted
- 3 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Conscious Sedation on Salivary Alpha-Amylase Levels in the Patients Undergoing Impacted Third Molar Surgery
- ClinicalTrials.gov ID
- NCT04207515
- Acronym / sponsor ID
- 2018/24
- Conditions
- Dental Anxiety, Dental Fear, Tooth Extraction Status Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 23 Dec 2019 (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.
The specific aims of the present study were to evaluate sAA responses to impacted third molar extractions at different time points in the patients under conscious sedation with local anesthesia and to examine the relationship between sAA, conscious sedation and dental anxiety. The null hypothesis was that conscious sedation could be considered to reduce salivary alpha amylase level during the wisdom tooth surgery.
Detailed description
In oral and maxillofacial surgery, surgical extraction of impacted third molars is one of the most common surgical techniques performed in the oral cavity. Conscious intravenous sedation could be administered for the patients to provide anxiolysis, sedation, and analgesia for the patient. Salivary alpha-amylase (sAA) which reflect stress-related changes in the autonomic nervous system (ANS), has been proposed as a non-invasive stress biomarker. The aim of the present study was to investigate whether salivary alpha amylase (sAA) levels could be decreased by conscious sedation in the patients undergoing impacted third molar extraction. A total of 18 male patients were recruited. All patients were administered Modified Dental Anxiety Scale (MDAS) test. Patients were divided into two groups: test group (procedures under sedation) and control group (procedures under local anesthesia). The following parameters were monitored at different study time-points: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SO2), and heart rate (HR). Five samples of saliva were taken from each patient: the first time patient came to clinic, the patient sat in the chair for extraction, before local anesthesia, immediately after extraction, at 4 h after extraction. The concentrations of sAA were measured and compared across the different stages of the study between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removal of wisdom tooth under conscious sedation | Experimental | Procedure: Procedures of wisdom tooth removal surgery under conscious sedationpatients were asked to fill MDAS form which consists of five questions. Systolic blood pressure, diastolic blood pressure, oxygen saturation , and heart rate were monitored at different time points: preoperative time ; intraoperative time-after local anesthesia , intraoperative time-after extraction , postoperative time . In this group removal of wisdom teeth was done under conscious sedation. During surgery procedures five saliva samples were collected. Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery. Ibuprofen (600 mg every 8 h for 7 days) and amoxicillin/clavulanate (875 mg/125 mg every 8 h for 5 days) were prescribed. Detailed explanation of oral hygiene techniques and recommendations for the postoperative period were given to each patient. |
| Removal of wisdom tooth under local anesthesia | Active comparator | Procedure: Procedures of wisdom tooth removal surgery under local anesthesiapatients were asked to fill MDAS form which consists of five questions. Systolic blood pressure, diastolic blood pressure , oxygen saturation , and heart rate were monitored at different time points: preoperative time ; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time. In this group, removal of wisdom teeth was done under local anesthesia. During surgery procedures five saliva samples were collected. Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery. Ibuprofen (600 mg every 8 h for 7 days) and amoxicillin/clavulanate (875 mg/125 mg every 8 h for 5 days) were prescribed. Detailed explanation of oral hygiene techniques and recommendations for the postoperative period were given to each patient. |
Who may qualify
- Ages
- 19 to 33 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Man
- 18-35 years
- individuals without chemotherapy or radiotherapy history
- individuals without antibiotics and NSAIDs history in the last month
- individuals without any medications that affect saliva content in the last 1 month
Key exclusion criteria (10 listed)
- Woman
- individuals with any systemic disorders
- individuals with chemotherapy and radiotherapy history
- individuals with antibiotics and NSAIDs history in the last month
- individuals with use of antibiotics and NSAIDs history in the last month
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 |
|---|---|---|
| Procedures of wisdom tooth removal surgery under conscious sedationThe first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery. | Procedure or surgery | Removal of wisdom tooth under conscious sedation |
| Procedures of wisdom tooth removal surgery under local anesthesiaThe first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery. | Procedure or surgery | Removal of wisdom tooth under local anesthesia |
Primary outcome
Salivary Alpha Amylase Level
Time frame: Change from baseline salivary alpha-amylase levels at different time points in one day
The measurement of salivary alpha amylase levels (t1. The first time the patient came to clinic, t2. When the patient sat in the chair for extraction, t3. Before local anesthesia, t4. Immediately after extraction, t5. 4 h after extraction)
4 secondary outcomes
Systolic blood pressure (SBP) level
Time frame: Change from baseline systolic blood pressure levels at different time points in one day
Diastolic blood pressure (DBP) level,
Time frame: Change from baseline diastolic blood pressure levels at different time points in one day
Oxygen saturation (SO2) level
Time frame: Change from baseline oxygen saturation levels at different time points in one day
Heart rate (HR) level
Time frame: Change from baseline heart rate levels at different time points in one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
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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.
Abdullah Tolga Şitilci principal investigator
Istanbul University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedures of wisdom tooth removal surgery under conscious sedation and Procedures of wisdom tooth removal surgery under local anesthesia in people with Dental Anxiety and Dental Fear, run by University of Beykent at 1 site in Turkey (Türkiye).
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 11 inclusion and 10 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: finished, as of the sponsor's last update on 23 Dec 2019. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Alpha Amylase Level (time frame: Change from baseline salivary alpha-amylase levels at different time points in one day). 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 23 Dec 2019.