Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations

NCT06605716 | Completed

• 1 other identifier: KutahyaHSU/BedreddinCavli/002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the frequency of trigeminocardiac reflex development during the surgical removal of large cystic structures within the maxillary and mandibular bones in healthy adults. The main questions it aims to answer are:

• What is the frequency of trigeminocardiac reflex development during the related surgical procedure?
• Does the frequency of TCR differ between the maxilla and mandible?
• Does the risk level for TCR increase in surgical procedures near vital structures (sinus floor, nasal floor, inferior alveolar nerve) depending on the size of the cyst?

Conditions

Trigeminocardiac Reflex; Jaw Cysts; Hemodynamic Instability

Keywords

Trigemino-Cardiac Reflex; Jaw cysts; Hemodynamic instability,

Outcome Measures

Primary Outcomes (3)

• Heart rate monitoring

  All patients in all research arms monitored prior to enucleation of cystic structures in the maxilla and mandible 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 enucleation of cystic structures in the maxilla and mandible 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 enucleation of cystic structures in the maxilla and mandible had their oxygen saturation monitored throughout the procedure.

  During the operation

Study Arms (2)

Maxilla

EXPERIMENTAL

Presence of cystic structures larger than 1 cm in the maxilla with a surgical indication for enucleation Healthy adults

Procedure: Enucleation of cysts

Mandibula

EXPERIMENTAL

Presence of cystic structures larger than 1 cm in the mandible with a surgical indication for enucleation Healthy adults

Procedure: Enucleation of cysts

Interventions

Enucleation of cysts PROCEDURE

Surgical removal of cystic structures larger than 1 cm in patients included in the study arms. Patients were monitored for TCR during the procedure.

Mandibula; Maxilla

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Patients with cystic lesions at least 1 cm in diameter in the maxilla and mandible
• Patients with no systemic health problems

You may not qualify if:

• Pregnant or breastfeeding female patients
• Patients with systemic health problems
• Patients with mental or neurological disorders
• Patients taking antidepressants

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya University of Health Sciences

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Jaw Cysts

Condition Hierarchy (Ancestors)

Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Study Officials

• Bedreddin Cavlı, Asst Prof

  Kutahya University of Health Sciences, Faculty of Dentistry

  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: July 8, 2024
• First Posted: September 20, 2024
• Study Start: February 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

TU (1)