Trigemino-Cardiac ReflexNCT06499532
The Frequency of Trigeminocardiac Reflex During the Extraction of Impacted Mandibular Wisdom Teeth
A study testing Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique and Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique in people with Trigemino-Cardiac Reflex and Impacted Third Molar Tooth, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate trigeminocardiac reflex (TCR) formation during surgical extraction of mandibular impacted wisdom teeth in healthy adults. The main questions it aims to answer are: How often is the TCR encountered during the extraction of impacted mandibular wisdom teeth? Do different… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigemino-Cardiac Reflex, Impacted Third Molar Tooth
- What is being tested?
- Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique and Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 10 Nov 2023
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old
- Will have impacted tooth extraction for the first time
- Extraction indication for mandibular impacted wisdom teeth
- Systemically healthy individuals
Who cannot join
- Patients with high anxiety
- Female patients who are pregnant or breastfeeding
- Individuals with any systemic disease
- Individuals with suspicion of cysts and/or tumors in the area of mandibular impacted wisdom teeth
- Patients with mental or neurological disorders
- Patients using antidepressants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya University of Health Sciences
Kütahya, 43100
About this study
Official title: The Frequency of Trigeminocardiac Reflex During the Extraction of Impacted Mandibular Wisdom Teeth and the Effect of Anesthesia Technique on the Development of the Reflex
The goal of this clinical trial is to investigate trigeminocardiac reflex (TCR) formation during surgical extraction of mandibular impacted wisdom teeth in healthy adults. The main questions it aims to answer are:
- How often is the TCR encountered during the extraction of impacted mandibular wisdom teeth?
- Do different local anesthesia techniques affect the frequency of this reflex?
- Is the relationship between the impacted teeth and the inferior alveolar nerve a predisposing factor for the development of this reflex
Read more
Researchers will monitor patients included in the study during the extraction of impacted mandibular wisdom teeth.
Patients will undergo an anxiety test, and those found to be anxious will be excluded from the study (to avoid vasovagal events).
During the procedure, at seven different surgical stages, blood pressure, oxygen saturation, and heart rate data will be recorded at the beginning and end of each stage.
The monitoring of TCR was conducted by observing a sudden bradycardia that developed within a few seconds and resolved when the procedure was paused, not preceded by any tachycardia. TCR will be investigated at three different levels according to different reference values in the literature.
Read the detailed description
The study included 40 patients who underwent extraction of impacted mandibular wisdom teeth.Before the surgical procedure, the two most commonly used local anesthesia techniques in oral surgical practice, GG and IASB techniques, were applied. While IASB was always accompanied by buccal and mylohyoid area supportive anesthesia, no additional anesthesia was required in any patient receiving GG anesthesia. Evaluation of the patients was done using panoramic radiographs. The closest distance between the roots of the relevant wisdom teeth and the inferior alveolar nerve (IAN) was recorded. In cases where the distance was less than 1 mm or where superimposition occurred, cone beam computed tomography (CBCT) images were taken from the patients to confirm the distance in three dimensions.
Patients were divided into two groups based on the proximity of their wisdom tooth roots to the IAN (within 1 mm or more than 1 mm) and into two groups based on the anesthesia technique to be applied (GG-IASB). Subgroups were named as GG-0 (more than 1 mm from IAN), GG-1 (within 1 mm from IAN), IASB-0 (more than 1 mm from IAN), and IASB-1 (within 1 mm from IAN). Ten patients were evenly selected for each subgroup (GG-0, GG-1, IASB-0, IASB-1).
The surgeries included in the study were performed by a single surgeon. Impacted wisdom teeth were vertical and consisted of teeth retained in bone. For the surgical procedure, a sleeve flap was applied including distal horizontal and vertical relaxing incisions near the mesial papilla of mandibular second molar tooth.
TCR monitoring was conducted by observing the occurrence of sudden bradycardia, which could develop within a few seconds and show improvement upon pausing the procedure, not preceded by tachycardia. To ensure accurate and timely monitoring of this sudden process and to monitor potential asystole that could develop, patients were monitored. Monitoring was conducted using 5-channel Contec Medical Systems (Hebei, China) monitors. Throughout the procedure, heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure, and oxygen saturation were recorded. Records were taken at six separate surgical stages: initially during local anesthesia administration, and subsequently during incision/flap removal, removal of bone barriers, crown elevation, root elevation, and during suturing. Any sudden changes occurring during the procedure were recorded along with their onset times.
In defining TCR (Trigeminocardiac Reflex) in the literature, various reference measurement methods include sudden drops in heart rate by more than 10%, more than 20%, or dropping below 60 beats per minute. To highlight these different proportional reference drop values, severity grading was used in the observed TCR findings. Sudden drops in heart rate between 10% and 20% were classified as mild TCR (TKR-1), drops exceeding 20% and heart rate falling below 60 bpm as moderate TCR (TKR-2), and the presence of asystole, syncope, or need for atropine application as severe TCR (TKR-3). The total TCR across all grades was termed as t-TCR. TCR calculation was based on heart rate measurements taken at the beginning of each surgical stage.
To exclude vasovagal syncope, commonly cited as a neurological emergency and etiological factor, and high anxiety from the study, patients were initially subjected to anxiety tests, and individuals with high anxiety levels were excluded from the study. Patient anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the State-Trait Anxiety Inventory-State scale (STAI-S).
- Being tested
- Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique, Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique
- Keywords
- Trigemino-Cardiac Reflex,, Impacted Third Molar Tooth, Hemodynamic instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia techniqueProcedure or surgery
The surgical removal of impacted mandibular wisdom teeth in patients included in the study arms was performed using Gow-Gates anesthesia technique. Patients were monitored for TCR during the procedure.
Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia techniqueProcedure or surgery
The surgical removal of impacted mandibular wisdom teeth in patients included in the study arms was performed using inferior alveolar nerve block anesthesia technique and supplemental anesthesia (buccal- mylohyoid). Patients were monitored for TCR during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Gow-gates anesthesia, distance to inferior alveolar nerve is more than 1 mm | Experimental | The extraction of impacted wisdom teeth in patients forming this study arm was performed using the Gow-Gates anesthesia technique. In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is greater than 1 mm. Receives: Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique |
| Gow-gates anesthesia, distance to inferior alveolar nerve is less than 1 mm | Experimental | The extraction of impacted wisdom teeth in patients forming this study arm was performed using the Gow-Gates anesthesia technique. In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is less than 1 mm. Receives: Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique |
| İnferior alveoler nerve block,distance to inferior alveolar nerve is more than 1 mm | Experimental | The extraction of impacted wisdom teeth in patients forming this study arm was performed using the inferior alveolar nerve block technique and supplemental anesthesia (buccal- mylohyoid). In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is greater than 1 mm. Receives: Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique |
| İnferior alveoler nerve block, distance to inferior alveolar nerve is less than 1 mm | Experimental | The extraction of impacted wisdom teeth in patients forming this study arm was performed using the inferior alveolar nerve block technique and supplemental anesthesia (buccal- mylohyoid). In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is less than 1 mm. Receives: Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate monitoring
All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their heart rate monitored throughout the procedure.
Measured: During the operation
Systolic, and diastolic blood pressure monitoring
All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their systolic, and diastolic blood pressure monitored throughout the procedure.
Measured: During the operation
Oxygen saturation monitoring
All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their oxygen saturation monitored throughout the procedure.
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigemino-Cardiac ReflexStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedreddin Cavlı, Kutahya Health Sciences University
- Investigators
- Bedreddin Cavlı, Asst. Professor, Principal investigator, Kutahya University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499532
- Sponsor's protocol ID
- KutahyaHSU/BedreddinCavli/001
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Trigeminocardiac Reflex During the Extraction of Impacted Mandibular Wisdom Teeth and the Effect of Anesthesia Technique on the Development of the Reflex
- ClinicalTrials.gov ID
- NCT06499532
- Acronym / sponsor ID
- KutahyaHSU/BedreddinCavli/001
- Keywords
- Trigemino-Cardiac Reflex,, Impacted Third Molar Tooth, Hemodynamic instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 12 Jul 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.
The goal of this clinical trial is to investigate trigeminocardiac reflex (TCR) formation during surgical extraction of mandibular impacted wisdom teeth in healthy adults. The main questions it aims to answer are:
- How often is the TCR encountered during the extraction of impacted mandibular wisdom teeth?
- Do different local anesthesia techniques affect the frequency of this reflex?
- Is the relationship between the impacted teeth and the inferior alveolar nerve a predisposing factor for the development of this reflex
Researchers will monitor patients included in the study during the extraction of impacted mandibular wisdom teeth.
Patients will undergo an anxiety test, and those found to be anxious will be excluded from the study (to avoid vasovagal events).
During the procedure, at seven different surgical stages, blood pressure, oxygen saturation, and heart rate data will be recorded at the beginning and end of each stage.
The monitoring of TCR was conducted by observing a sudden bradycardia that developed within a few seconds and resolved when the procedure was paused, not preceded by any tachycardia. TCR will be investigated at three different levels according to different reference values in the literature.
Detailed description
The study included 40 patients who underwent extraction of impacted mandibular wisdom teeth.Before the surgical procedure, the two most commonly used local anesthesia techniques in oral surgical practice, GG and IASB techniques, were applied. While IASB was always accompanied by buccal and mylohyoid area supportive anesthesia, no additional anesthesia was required in any patient receiving GG anesthesia. Evaluation of the patients was done using panoramic radiographs. The closest distance between the roots of the relevant wisdom teeth and the inferior alveolar nerve (IAN) was recorded. In cases where the distance was less than 1 mm or where superimposition occurred, cone beam computed tomography (CBCT) images were taken from the patients to confirm the distance in three dimensions.
Patients were divided into two groups based on the proximity of their wisdom tooth roots to the IAN (within 1 mm or more than 1 mm) and into two groups based on the anesthesia technique to be applied (GG-IASB). Subgroups were named as GG-0 (more than 1 mm from IAN), GG-1 (within 1 mm from IAN), IASB-0 (more than 1 mm from IAN), and IASB-1 (within 1 mm from IAN). Ten patients were evenly selected for each subgroup (GG-0, GG-1, IASB-0, IASB-1).
The surgeries included in the study were performed by a single surgeon. Impacted wisdom teeth were vertical and consisted of teeth retained in bone. For the surgical procedure, a sleeve flap was applied including distal horizontal and vertical relaxing incisions near the mesial papilla of mandibular second molar tooth.
TCR monitoring was conducted by observing the occurrence of sudden bradycardia, which could develop within a few seconds and show improvement upon pausing the procedure, not preceded by tachycardia. To ensure accurate and timely monitoring of this sudden process and to monitor potential asystole that could develop, patients were monitored. Monitoring was conducted using 5-channel Contec Medical Systems (Hebei, China) monitors. Throughout the procedure, heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure, and oxygen saturation were recorded. Records were taken at six separate surgical stages: initially during local anesthesia administration, and subsequently during incision/flap removal, removal of bone barriers, crown elevation, root elevation, and during suturing. Any sudden changes occurring during the procedure were recorded along with their onset times.
In defining TCR (Trigeminocardiac Reflex) in the literature, various reference measurement methods include sudden drops in heart rate by more than 10%, more than 20%, or dropping below 60 beats per minute. To highlight these different proportional reference drop values, severity grading was used in the observed TCR findings. Sudden drops in heart rate between 10% and 20% were classified as mild TCR (TKR-1), drops exceeding 20% and heart rate falling below 60 bpm as moderate TCR (TKR-2), and the presence of asystole, syncope, or need for atropine application as severe TCR (TKR-3). The total TCR across all grades was termed as t-TCR. TCR calculation was based on heart rate measurements taken at the beginning of each surgical stage.
To exclude vasovagal syncope, commonly cited as a neurological emergency and etiological factor, and high anxiety from the study, patients were initially subjected to anxiety tests, and individuals with high anxiety levels were excluded from the study. Patient anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the State-Trait Anxiety Inventory-State scale (STAI-S).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gow-gates anesthesia, distance to inferior alveolar nerve is more than 1 mm | Experimental | Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia techniqueThe extraction of impacted wisdom teeth in patients forming this study arm was performed using the Gow-Gates anesthesia technique. In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is greater than 1 mm. |
| Gow-gates anesthesia, distance to inferior alveolar nerve is less than 1 mm | Experimental | Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia techniqueThe extraction of impacted wisdom teeth in patients forming this study arm was performed using the Gow-Gates anesthesia technique. In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is less than 1 mm. |
| İnferior alveoler nerve block,distance to inferior alveolar nerve is more than 1 mm | Experimental | Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia techniqueThe extraction of impacted wisdom teeth in patients forming this study arm was performed using the inferior alveolar nerve block technique and supplemental anesthesia (buccal- mylohyoid). In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is greater than 1 mm. |
| İnferior alveoler nerve block, distance to inferior alveolar nerve is less than 1 mm | Experimental | Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia techniqueThe extraction of impacted wisdom teeth in patients forming this study arm was performed using the inferior alveolar nerve block technique and supplemental anesthesia (buccal- mylohyoid). In these patients, the distance between the wisdom teeth and the inferior alveolar nerve is less than 1 mm. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-30 years old
- Will have impacted tooth extraction for the first time
- Extraction indication for mandibular impacted wisdom teeth
- Systemically healthy individuals
Key exclusion criteria (6 listed)
- Patients with high anxiety
- Female patients who are pregnant or breastfeeding
- Individuals with any systemic disease
- Individuals with suspicion of cysts and/or tumors in the area of mandibular impacted wisdom teeth
- Patients with mental or neurological disorders
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 |
|---|---|---|
| Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia techniqueThe surgical removal of impacted mandibular wisdom teeth in patients included in the study arms was performed using Gow-Gates anesthesia technique. Patients were monitored for TCR during the procedure. | Procedure or surgery | Gow-gates anesthesia, distance to inferior alveolar nerve is less than 1 mm, Gow-gates anesthesia, distance to inferior alveolar nerve is more than 1 mm |
| Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia techniqueThe surgical removal of impacted mandibular wisdom teeth in patients included in the study arms was performed using inferior alveolar nerve block anesthesia technique and supplemental anesthesia (buccal- mylohyoid). Patients were monitored for TCR during the procedure. | Procedure or surgery | İnferior alveoler nerve block, distance to inferior alveolar nerve is less than 1 mm, İnferior alveoler nerve block,distance to inferior alveolar nerve is more than 1 mm |
Primary outcome
Heart rate monitoring
Time frame: During the operation
All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their heart rate monitored throughout the procedure.
Systolic, and diastolic blood pressure monitoring
Time frame: During the operation
All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their systolic, and diastolic blood pressure monitored throughout the procedure.
Oxygen saturation monitoring
Time frame: During the operation
All patients in all research arms monitored prior to extraction of impacted mandibular wisdom teeth had their oxygen saturation monitored throughout the procedure.
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 12 Jul 2024.
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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.
Bedreddin Cavlı, Asst. Professor principal investigator
Kutahya University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia technique and Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique in people with Trigemino-Cardiac Reflex and Impacted Third Molar Tooth, run by Kutahya Health Sciences University 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 4 inclusion and 6 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 12 Jul 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 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?
Heart rate monitoring (time frame: During the operation). The study lists 3 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 12 Jul 2024.