NCT06499532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

June 30, 2024

Last Update Submit

July 10, 2024

Conditions

Trigemino-Cardiac ReflexImpacted Third Molar Tooth

Keywords

Trigemino-Cardiac Reflex,Impacted Third Molar ToothHemodynamic instability

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    During the operation

Study Arms (4)

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.

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.

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.

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.

Procedure: Monitoring and Surgical removal of mandibular impacted wisdom teeth, using inferior alveolar nerve block anesthesia technique

Interventions

Monitoring and Surgical removal of mandibular impacted wisdom teeth, using Gow-Gates anesthesia techniquePROCEDURE

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.

Gow-gates anesthesia, distance to inferior alveolar nerve is less than 1 mmGow-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 techniquePROCEDURE

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.

İnferior alveoler nerve block, distance to inferior alveolar nerve is less than 1 mmİnferior alveoler nerve block,distance to inferior alveolar nerve is more than 1 mm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Will have impacted tooth extraction for the first time
  • Extraction indication for mandibular impacted wisdom teeth
  • Systemically healthy individuals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya University of Health Sciences

Kütahya, 43100, Turkey (Türkiye)

Location

Study Officials

  • Bedreddin Cavlı, Asst. Professor

    Kutahya University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

June 30, 2024

First Posted

July 12, 2024

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 10, 2023

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

TU(1)