A Study of the Trigeminal Cardio-Reflex in Endodontic and... | NCT02745782

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

NCT02745782

Sponsor

YI SHENG HUANG

Status

Unknown status

Last Update Posted

Apr 20, 2016Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Pulpitis

Interventions

Observational Study

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Sep 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Apr 9, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

YI SHENG HUANG, Professor, Chung Shan Medical UniversitySponsor-Investigator

Lead Sponsor

YI SHENG HUANGOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational Study	Other	Observational Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tsui Hsien Huang, Ph.D	Contact	+886 919 707 088		thh@csmu.edu.tw
Yi Sheng Huang	Contact	+886 910 320 616		jamestda@ms79.hinet.net

Overall Officials

Name	Affiliation	Role
Tsui Hsien Huang, Ph.D	CSMU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University Hospital	Recruiting	Taichung			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23332411	Background	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.
22240287	Background	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.

ID	Term
D011671	Pulpitis
D013575	Syncope

ID	Term
D003788	Dental Pulp Diseases
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D014474	Unconsciousness

ID	Term
D008722	Methods
D008919	Investigative Techniques