Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499532
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-30
Brief Title:
The Frequency of Trigeminocardiac Reflex During the Extraction of Impacted Mandibular Wisdom Teeth
Sponsor:
Kutahya Health Sciences University
Organization:
Kutahya Health Sciences University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 teethBefore 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 incisionflap 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
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 incisionflap 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None