AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Turkey (Türkiye)

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 groups in NCT06499532
Study groupRoleWhat they receive
Gow-gates anesthesia, distance to inferior alveolar nerve is more than 1 mmExperimentalThe 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 mmExperimentalThe 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 mmExperimentalThe 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 mmExperimentalThe 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.

  1. 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

  2. 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

  3. 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.

  1. First posted12 Jul 2024
  2. Study start1 Oct 2023
  3. Primary completion1 Nov 2023
  4. Study completion10 Nov 2023

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in