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

Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745782
• Other study ID #: CS 14112
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2016
• Last updated: April 19, 2016
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: April 2016
• Source: Chung Shan Medical University
• Contact: Tsui Hsien Huang, Ph.D
• Phone: +886 919 707 088
• Email: thh[@]csmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulpitis

Intervention

Other:
• Observational Study
Observational Study

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
YI SHENG HUANG

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Bohluli B, Ashtiani AK, Khayampoor A, Sadr-Eshkevari P. Trigeminocardiac reflex: a MaxFax literature review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Aug;108(2):184-8. doi: 10.1016/j.tripleo.2009.03.050. Review. — View Citation

Lübbers HT, Zweifel D, Grätz KW, Kruse A. Classification of potential risk factors for trigeminocardiac reflex in craniomaxillofacial surgery. J Oral Maxillofac Surg. 2010 Jun;68(6):1317-21. doi: 10.1016/j.joms.2009.12.039. Epub 2010 Mar 29. Review. — View Citation

Schaller B, Probst R, Strebel S, Gratzl O. Trigeminocardiac reflex during surgery in the cerebellopontine angle. J Neurosurg. 1999 Feb;90(2):215-20. — View Citation

Schipke JD, Cleveland S, Caspers C. Computer-assisted paranasal sinus operation induces diving bradycardia. Am J Otolaryngol. 2013 Jul-Aug;34(4):353-4. doi: 10.1016/j.amjoto.2012.12.004. Epub 2013 Jan 14. — View Citation

Yorgancilar E, Gun R, Yildirim M, Bakir S, Akkus Z, Topcu I. Determination of trigeminocardiac reflex during rhinoplasty. Int J Oral Maxillofac Surg. 2012 Mar;41(3):389-93. doi: 10.1016/j.ijom.2011.12.025. Epub 2012 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Blood Pressure(MABP) lower than 20%		Through routine dental treatment completion, an average of 1 hour	No
Primary	Heart Rate (HR): lower than 60 beats/ minute		Through routine dental treatment completion, an average of 1 hour	No