Clinical trial NCT02745782: A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment
Official title: A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulpitis
Keywords: Pulpitis
Syncope
Trigeminal Cardio-Reflex
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators collected data from adult patients who agreed to participate in the study and accepted relevant treatments including filling, extraction, scaling, implant, and crown bridge preparation (no more than 500 patients in each treatment item) before September 2016. Previous studies shows that TCR is more often happen in young patients. Therefore, to avoid ethical issue, adult patients are more suitable in this study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients aged under 20

Primary outcomes:
measure: Mean Arterial Blood Pressure(MABP) lower than 20%
timeFrame: Through routine dental treatment completion, an average of 1 hour
measure: Heart Rate (HR): lower than 60 beats/ minute
timeFrame: Through routine dental treatment completion, an average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: CSMU
name: Tsui Hsien Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: Lubbers HT, Zweifel D, Gratz 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.
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. doi: 10.3171/jns.1999.90.2.0215.