A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment

• Conditions: Pulpitis

• Registration Number: NCT02745782
• Lead Sponsor: YI SHENG HUANG

Brief Summary

This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.

Detailed Description

This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.

Previous Trigemino-Cardiac Reflex(TCR) related studies reported that stimulation of trigeminal nerve induces trigeminal nerve reflection, and then causes blood pressure rapidly decreasing. Finally, sudden blood pressure decreasing results in syncope. Clinical data has been collected and analyzed in the past four months, and the primary results showed significantly difference. This phenomenon may be probably observed in other dental treatments. Hence, the objective of this study is to remind clinical dentists to monitor patients' physical conditions when conducting root canal relevant treatments and to avoid situations such as syncope, and reduce medical disputes and benefit dentists and patient as a result. In the recent year, syncope often occurs during denture procedures. The value of this study will inform clinical dentist to notice risk of dental relative treatments. In addition, it will improve patients' safety.

Study Timeline

• Study Start: 2014-10
• Status Verified: 2016-04
• Study First Submitted: 2016-04-09
• Study First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Study First Posted: 2016-04-20
• Last Update Posted: 2016-04-20
• Primary Completion: 2017-09
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients who sign the informed consent forms
• Patients with Pulpitis
• Patients aged 20 or order

Exclusion Criteria

• Patients aged under 20

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Arterial Blood Pressure(MABP) lower than 20%	Through routine dental treatment completion, an average of 1 hour
Heart Rate (HR): lower than 60 beats/ minute	Through routine dental treatment completion, an average of 1 hour

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan