NCT02745782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

April 9, 2016

Last Update Submit

April 19, 2016

Conditions

Pulpitis

Keywords

PulpitisSyncopeTrigeminal Cardio-Reflex

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Observational StudyOTHER

Observational Study

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients aged under 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23332411BACKGROUND

  • 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.

    PMID: 22240287BACKGROUND

  • 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.

    PMID: 19615657BACKGROUND

  • 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.

    PMID: 20347202BACKGROUND

  • 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.

    PMID: 9950491BACKGROUND

MeSH Terms

Conditions

PulpitisSyncope

Interventions

Observation

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Tsui Hsien Huang, Ph.D

    CSMU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsui Hsien Huang, Ph.D

CONTACT

+886 919 707 088thh@csmu.edu.tw

Yi Sheng Huang

CONTACT

+886 910 320 616jamestda@ms79.hinet.net

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2016

First Posted

April 20, 2016

Study Start

October 1, 2014

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)